MDR Data Files
Each year, the FDA receives over two million medical device reports of suspected device-associated deaths, serious injuries, and malfunctions. These medical device reports have been available in the FDA's public Manufacturer and User Facility Device Experience (MAUDE) database since 1999 as one source of information to help patients and health care providers make more informed medical decisions.
On this page, the FDA is also providing the medical device reports received from 1984 - 1996 through CDRH's legacy Device Experience Network (DEN) reporting system and reports received under the Alternative Summary Reporting Program from 1999 – April 2019.
Under the Freedom of Information and Privacy Acts (Sec. 552, Title 5, USC) (PL 93-579), the FDA is required to delete, prior to public disclosure, any information that constitutes trade secrets, and confidential, commercial, or financial information; and any personal, medical and similar information that would constitute a clearly unwarranted invasion of personal privacy. Included in the deletion requirements are all identification of the reporters of the events and the user facility where the event occurred.
On this page:
- MAUDE downloadable files
- Alternative Summary Reports
- ASR Data File Values
- Device Experience Network (DEN) Reports
MAUDE Data Downloadable Files
This section provides downloadable zipped data files that consist of:
- Voluntary reports since June 1993
- User facility reports since 1991
- Distributor reports since 1993
- Manufacturer reports since August 1996
This data is provided in zip files, which are updated monthly.
The MDR data is presented in tables and contains all publicly available information from the completed the MEDWATCH Form 3500. The FDA recommends downloading all types of files for the time period of interest.
Tip for Downloading Files
- When downloading the MDR data files to a database such as Microsoft Access, we recommend that you first open, then save the data file in Microsoft WORD. This will add an "end of record" marker to each MDR record that can be recognized by Microsoft ACCESS. For files such as the FOIDEV files, you may need to put in an extra character at the end of the first record prior to importing the file, otherwise the last column of data may be lost.
Tips for Reviewing the Downloaded Files
- Field Definitions:
- Master Event Data: A distinct master event data record will be present for each source reporting an event. In other words, if a User Facility, Distributor, Manufacturer, and voluntary submitter all report an event, there will be four event records.
- Device Data: Contains information related to the device(s) involved in the event.
- Patient Data: Contains information related to the patient(s) involved in the event.
- Text Data: Contains textual information from MEDWATCH Form Sections B5, H3, and H10.
- Device Problem Data: Contains Device Problem Code data from MEDWATCH Form Sections F10 and H6
- Patient Problem Data: Contains Health Effect – Clinical Code (previously labeled "Patient Code") data from MEDWATCH Form Sections F10 and H6
- All record types are linked by the MDR REPORT KEY, found in each file.
- For distributor reports that also had subsequent manufacturer reports, a special data element, MANUFACTURER LINK FLAG, will be set to 'Y'. In this case, the DISTRIBUTOR information (Section F on the master event data record) will be present; otherwise, these data elements will be blank.
The following files are available: (File Sizes are approximate)
File Name | Compressed Size in Bytes | Uncompressed Size in Bytes | Total Records | Description |
---|---|---|---|---|
mdrfoi.zip | 20019KB | 185430KB | 586204 | MAUDE Base records received to date for 2024 |
mdrfoithru2023.zip | 598951KB | 5800337KB | 18118160 | Master Record through 2023 |
mdrfoiadd.zip | 6664KB | 61873KB | 196195 | New MAUDE Base records for the current month. |
mdrfoichange.zip | 29532KB | 238353KB | 720130 | MAUDE Base data updates: changes to existing Base data. |
patient.zip | 3347KB | 24846KB | 585380 | MAUDE Patient records received to date for 2024 |
patientthru2023.zip | 95313KB | 687674KB | 18104231 | Patient Record through 2023 |
patientadd.zip | 1119KB | 8341KB | 196146 | New MAUDE Patient records for the current month. |
patientchange.zip | 3612KB | 23763KB | 560810 | MAUDE Patient data updates: changes to existing Base data. |
patientproblemcode.zip | 132307KB | 1277965KB | 18544264 | MAUDE Patient records for problemcode |
patientproblemdata.zip | 11KB | 25KB | 998 | Patient Problem Data |
foidevthru1997.zip | 6001KB | 31217KB | 136917 | Device Data through 1997 |
foidev1998.zip | 3205KB | 17539KB | 63440 | Device Data for 1998 |
foidev1999.zip | 2764KB | 14798KB | 52880 | Device Data for 1999 |
device2000.zip | 1932KB | 9998KB | 53114 | Device Data for 2000 |
device2001.zip | 2126KB | 11075KB | 59073 | Device Data for 2001 |
device2002.zip | 2321KB | 12967KB | 70384 | Device Data for 2002 |
device2003.zip | 2527KB | 14242KB | 77949 | Device Data for 2003 |
device2004.zip | 2803KB | 14944KB | 82887 | Device Data for 2004 |
device2005.zip | 3350KB | 17711KB | 99770 | Device Data for 2005 |
device2006.zip | 3966KB | 21308KB | 120486 | Device Data for 2006 |
device2007.zip | 4820KB | 30277KB | 172205 | Device Data for 2007 |
device2008.zip | 5521KB | 34034KB | 195474 | Device Data for 2008 |
device2009.zip | 6724KB | 43739KB | 243108 | Device Data for 2009 |
device2010.zip | 8724KB | 56054KB | 304407 | Device Data for 2010 |
device2011.zip | 11585KB | 80802KB | 446880 | Device Data for 2011 |
device2012.zip | 13376KB | 88104KB | 487770 | Device Data for 2012 |
device2013.zip | 17746KB | 124537KB | 682402 | Device Data for 2013 |
device2014.zip | 20349KB | 159694KB | 863841 | Device Data for 2014 |
device2015.zip | 23406KB | 169708KB | 862910 | Device Data for 2015 |
device2016.zip | 26283KB | 180365KB | 868406 | Device Data for 2016 |
device2017.zip | 31495KB | 206501KB | 938709 | Device Data for 2017 |
device2018.zip | 37399KB | 236717KB | 1050403 | Device Data for 2018 |
device2019.zip | 45834KB | 307819KB | 1333421 | Device Data for 2019 |
device2020.zip | 50531KB | 362572KB | 1567522 | Device Data for 2020 |
device2021.zip | 60714KB | 460732KB | 2031092 | Device Data for 2021 |
device2022.zip | 73543KB | 658474KB | 2949848 | Device Data for 2022 |
device2023.zip | 72603KB | 529420KB | 2341694 | Device Data for 2023 |
device.zip | 18058KB | 128770KB | 586509 | Device Data received to date for 2024 |
deviceadd.zip | 6423KB | 44425KB | 196189 | New MAUDE Device data for the current month. |
devicechange.zip | 26507KB | 162852KB | 721305 | Device data updates: changes to existing Device data and additional Device data for existing Base records. |
deviceproblemcodes.zip | 16KB | 42KB | 1704 | Device Problem Data |
foidevproblem.zip | 48343KB | 266605KB | 18740111 | Device Data for foidevproblem |
foitextthru1995.zip | 3561KB | 16551KB | 27401 | Narrative data through 1995 |
foitext1996.zip | 2782KB | 9318KB | 32059 | Narrative Data for 1996 |
foitext1997.zip | 7557KB | 26382KB | 91009 | Narrative Data for 1997 |
foitext1998.zip | 5924KB | 20773KB | 68316 | Narrative Data for 1998 |
foitext1999.zip | 4501KB | 15788KB | 51119 | Narrative Data for 1999 |
foitext2000.zip | 4760KB | 16491KB | 52625 | Narrative Data for 2000 |
foitext2001.zip | 5090KB | 17763KB | 57986 | Narrative Data for 2001 |
foitext2002.zip | 6089KB | 22304KB | 64859 | Narrative Data for 2002 |
foitext2003.zip | 6221KB | 23332KB | 66241 | Narrative Data for 2003 |
foitext2004.zip | 6090KB | 21742KB | 56117 | Narrative Data for 2004 |
foitext2005.zip | 9649KB | 34692KB | 95044 | Narrative Data for 2005 |
foitext2006.zip | 20092KB | 69183KB | 177414 | Narrative Data for 2006 |
foitext2007.zip | 25177KB | 88484KB | 232627 | Narrative Data for 2007 |
foitext2008.zip | 28286KB | 101218KB | 264972 | Narrative Data for 2008 |
foitext2009.zip | 40869KB | 147687KB | 388042 | Narrative Data for 2009 |
foitext2010.zip | 62269KB | 252984KB | 635654 | Narrative Data for 2010 |
foitext2011.zip | 94583KB | 425073KB | 1040278 | Narrative Data for 2011 |
foitext2012.zip | 108957KB | 475208KB | 1167621 | Narrative Data for 2012 |
foitext2013.zip | 139507KB | 622562KB | 1609332 | Narrative Data for 2013 |
foitext2014.zip | 164295KB | 788040KB | 1948365 | Narrative Data for 2014 |
foitext2015.zip | 184834KB | 861735KB | 2073784 | Narrative Data for 2015 |
foitext2016.zip | 194760KB | 924811KB | 2180342 | Narrative Data for 2016 |
foitext2017.zip | 216530KB | 1076093KB | 2365712 | Narrative Data for 2017 |
foitext2018.zip | 213901KB | 1085673KB | 2629641 | Narrative Data for 2018 |
foitext2019.zip | 317948KB | 1790447KB | 3463465 | Narrative Data for 2019 |
foitext2020.zip | 332040KB | 2013022KB | 4010065 | Narrative Data for 2020 |
foitext2021.zip | 384265KB | 2280855KB | 4858175 | Narrative Data for 2021 |
foitext2022.zip | 460860KB | 3288915KB | 6602458 | Narrative Data for 2022 |
foitext2023.zip | 471143KB | 3047758KB | 5236030 | Narrative Data for 2023 |
foitext.zip | 86803KB | 600808KB | 1145273 | Narrative Data received to date for 2024 |
foitextadd.zip | 27164KB | 180560KB | 370238 | New MAUDE Narrative data for the current month. |
foitextchange.zip | 199961KB | 1126943KB | 1592615 | Narrative data updates: changes to existing narrative data and additional narrative data for existing base records. |
Note: This documentation is intended to be used in conjunction with a copy of Medwatch Form 3500A and 3500.
Record/Data Characteristics:
- The data has one record per line, with the data fields in a pipe-delimited, (i.e., "|") format
- All data elements are alpha-numeric
- All text fields contain whatever data was provided/entered. If no information was provided/entered the field will be left empty. If an asterisk ("*") is present, it represents what was entered on the 3500/3500A.
- All "FLAG" data elements have the value of "Y" for Yes, "N" for No, or are blank if no data was available/entered.
- All fields identified as multiply-occurring represent data elements which may have multiple values. Each value will be present in the field, separated by a comma. The word "OTHER" may appear as one of the values if the "Other" box was checked off. If the whole field is blank, no data was reported/entered.
- Section G CONTACT address information may not necessarily be the address where the device is manufactured.
Special Note for REPORT NUMBER data element:
The REPORT NUMBER data element represents Manufacturer Report Number, Distributor Report Number, or internally-generated voluntary report number, depending on the source of the record.
This REPORT NUMBER field will be blank when:
- User Facility submitted the report
- Distributor report has not been followed by a subsequent Manufacturer report.
Special Notes for Voluntary Reports and User Facility Malfunction Reports:
The only data elements which will be present on the Master Event Record will be:
- NEW RECORD
- DEVICE EVENT KEY
- REPORT SOURCE CODE
- MDR REPORT KEY
- Section B
All other data elements will be blank.
MDRFOI file contains following 82 fields, delimited by pipe (|), one record per line:
- MDR Report Key
- Empty field (not used)
- Report Number
- Report Source Code
- P = Voluntary report
- U = User Facility report
- D = Distributor report
- M = Manufacturer report
- Manufacturer Link Flag (internal information flag)
- Number Devices in Event (if source code is 'P', field will be null)
- Number Patient in Event (if source code is 'P', field will be null)
- Date Received
SECTION-B
- Adverse Event Flag (B1)
- Product Problem Flag (B1)
- Date Report (B4)
- Date of Event (B3) -- new added, 2006
- Single Use Flag (Reprocessor Flag) (D8) -- new added, 2006
- Reporter Occupation Code (E3) -- new added, 2006
* INVALID DATA
- 000 OTHER
- 001 PHYSICIAN
- 002 NURSE
- 003 NON-HEALTHCARE PROFESSIONAL
- 0HP HEALTH PROFESSIONAL
- 0LP LAY USER/PATIENT
- 100 OTHER HEALTH CARE PROFESSIONAL
- 101 AUDIOLOGIST
- 102 DENTAL HYGIENIST
- 103 DIETICIAN
- 104 EMERGENCY MEDICAL TECHNICIAN
- 105 MEDICAL TECHNOLOGIST
- 106 NUCLEAR MEDICINE TECHNOLOGIST
- 107 OCCUPATIONAL THERAPIST
- 108 PARAMEDIC
- 109 PHARMACIST
- 110 PHLEBOTOMIST
- 111 PHYSICAL THERAPIST
- 112 PHYSICIAN ASSISTANT
- 113 RADIOLOGIC TECHNOLOGIST
- 114 RESPIRATORY THERAPIST
- 115 SPEECH THERAPIST
- 116 DENTIST
- 117 NURSE PRACTITIONER
- 300 OTHER CAREGIVERS
- 301 DENTAL ASSISTANT
- 302 HOME HEALTH AIDE
- 303 MEDICAL ASSISTANT
- 304 NURSING ASSISTANT
- 305 PATIENT
- 306 PATIENT FAMILY MEMBER OR FRIEND
- 307 PERSONAL CARE ASSISTANT
- 400 SERVICE AND TESTING PERSONNEL
- 401 BIOMEDICAL ENGINEER
- 402 HOSPITAL SERVICE TECHNICIAN
- 403 MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
- 404 PHYSICIST
- 405 SERVICE PERSONNEL
- 499 DEVICE UNATTENDED
- 500 RISK MANAGER
- 501 ADMINISTRATOR/SUPERVISOR
- 600 ATTORNEY
- 999 UNKNOWN
- NA NOT APPLICABLE
- NI NO INFORMATION
- UNK UNKNOWN
SECTION-E (if source code is 'P', Section E to H will contain no data)
- Health Professional (E2)
- Initial Report to FDA (E4)
- Y = Yes
- N = No
- U = Unknown
- * = No answer provided
SECTION-F
- Date Facility Aware (F6)
- Report Date (F8)
- Report to FDA (F11)
- Date Report to FDA (F11)
- Event Location (F12)
- Date Report to Manufacturer (F13)
SECTION-G (only for report source 'M', others sources will be null)
- Manufacturer Contact Title Name (G1)
- Manufacturer Contact First Name (G1)
- Manufacturer Contact Last Name (G1)
- Manufacturer Contact Street 1 (G1)
- Manufacturer Contact Street 2 (G1)
- Manufacturer Contact City (G1)
- Manufacturer Contact State Code (G1)
- Manufacturer Contact Zip Code (G1)
- Manufacturer Contact Zip Code Ext (G1)
- Manufacturer Contact Country Code
- Manufacturer Contact Postal Code
- Manufacturer Contact Phone No Area Code (G1)
- Manufacturer Contact Phone No Exchange (G2)
- Manufacturer Contact Phone No (G2)
- Manufacturer Contact Phone No Ext (G2)
- Manufacturer Contact Phone No Country Code
- Manufacturer Contact Phone No City Code
- Manufacturer Contact Phone No Local
- Manufacturer G1 Name (G1)
- Manufacturer G1 Street 1 (G1)
- Manufacturer G1 Street 2 (G1)
- Manufacturer G1 City (G1)
- Manufacturer G1 State Code (G1)
- Manufacturer G1 Zip Code (G1)
- Manufacturer G1 Zip Code Ext (G1)
- Manufacturer G1 Country Code
- Manufacturer G1 Postal Code
- Date Manufacturer Received (G4)
SECTION-H
- Device Date Of Manufacture (H4)
- Single Use Flag (H5)
- Remedial Action (H7) -- multiple source type, separate by ','
- RC = Recall
- RP = Repair
- RL = Replace
- RB = Relabeling
- OT = Other
- NO = Notification
- IN = Inspection
- PM = Patient Monitoring
- MA = Modification/Adjustment
- * = Invalid Data
- Previous Use Code (H8)
- Removal/Correction Number (H9)
- Event type (H1) -- only relevant for report sourcetype 'M'
- D = Death
- IN = Injury
- IL = Injury
- IJ = Injury
- M = Malfunction
- O = Other
- * = No answer provided
- Distributor Name (F3) -- if report source code = 'M' and
- Distributor Address line 1 (F3)
- Distributor Address line 2 (F3)
- Distributor City (F3)
- Distributor State Code (F3)
- Distributor Zip Code (F3)
- Distributor Zip Code Ext (F3)
- Report to Manufacturer (F13)
- Manufacturer Name (F14)
- Manufacturer Address line 1 (F14)
- Manufacturer Address line 2 (F14)
- Manufacturer City (F14)
- Manufacturer State Code (F14)
- Manufacturer Zip Code (F14)
- Manufacturer Zip Code Ext (F14)
- Manufacturer Country Code (F14)
- Manufacturer Postal Code (F14)
- Type of Report (F7) !multiple submission type, separate by ','
- I = Initial submission
- F = Followup
- X = Extra copy received
- O = Other information submitted
- Source Type (G3) -- multiple source type, separate by ','
- 00 Other
- 01 Foreign
- 02 Study
- 03 Literature
- 04 Consumer
- 05 Health Professional
- 06 User facility
- 07 Company representation
- 08 Distributor
- 99 Unknown
- * Invalid data
- Date Added
- Date Changed
- Reporter Country Code
- PMA PMN Number
- Exemption Number
- Summary Report
- NOE Summary
- Suppl Dates FDA Received
- Suppl Dates MFR Received
DEVICE file contains following 48 fields, delimited by pipe (|), one record per line:
- MDR Report Key
- Device Event key
- Implant Flag -- D6, new added; 2006
- Date Removed Flag -- D7, new added; 2006; if flag in M or Y, print Date
- U = Unknown
- A = Not available
- I = No information at this time
- M = Month and year provided only, day defaults to 01
- Y = Year provided only, day defaulted to 01, month defaulted to January
- Device Sequence No -- from device report table
- Date Received (from mdr_document table)
SECTION-D
- Brand Name (D1)
- Generic Name (D2)
- Manufacturer Name (D3)
- Manufacturer Address 1 (D3)
- Manufacturer Address 2 (D3)
- Manufacturer City (D3)
- Manufacturer State Code (D3)
- Manufacturer Zip Code (D3)
- Manufacturer Zip Code ext (D3)
- Manufacturer Country Code (D3)
- Manufacturer Postal Code (D3)
- Device Operator (D5)
- Expiration Date of Device (D4)
- Model Number (D4)
- Catalog Number (D4)
- Lot Number (D4)
- Other ID Number (D4)
- Device Availability (D10)
- Y = Yes
- N = No
- R = Device was returned to manufacturer
- * = No answer provided
- Date Returned to Manufacturer (D10)
- Device Report Product Code
- Device Age (F9)
- Device Evaluated by Manufacturer (H3)
- Y = Yes
- N = No
- R = Device not returned to manufacturer
- * = No answer provided
- Combination Product Flag (G4)
- Y = Yes
- N = No
- UDI-DI
- UDI-Public
BASELINE SECTION (for records prior to 2009)
- Baseline brand name
- Baseline generic name
- Baseline model no
- Baseline catalog no
- Baseline other id no
- Baseline device family
- Baseline shelf life contained in label
- Y = Yes
- N = No
- A = Not applicable
- * = No answer provided
- Baseline shelf life in months
- Baseline PMA flag
- Baseline PMA no
- Baseline 510(k) flag
- Baseline 510(k) no
- Baseline preamendment
- Baseline transitional
- Baseline 510(k exempt flag
- Baseline date) first marketed
- Baseline date ceased marketing
PATIENT file contains following 10 fields, delimited by pipe (|), one record per line:
- MDR Report Key (from patient report table)
- Patient Sequence Number (from patient report table)
- Date Received (from mdr_document table)
- Sequence Number||','|| Treatment -- multiple source type, separate by ';'
- Sequence Number||','|| Outcome -- multiple source type, separate by ';'
- L - Life Threatening
- H - Hospitalization
- S - Disability
- C - Congenital Anomaly
- R - Required Intervention
- O - Other
- * - Invalid Data
- U - Unknown
- I - No Information
- A - Not Applicable
- D - Death
- Patient Age
- Patient Sex
- Patient Weight
- Patient Ethnicity
- Patient Race
TEXT file contains following 6 fields, delimited by pipe (|), one record per line:
- MDR Report Key
- MDR Text Key
- Text Type Code (D=B5, E=H3, N=H10 from mdr_text table)
- Patient Sequence Number (from mdr_text table)
- Date Report (from mdr_text table)
- Text (B5, or H3 or H10 from mdr_text table)
FOIDEVPROBLEM contains 2 fields, delimited by pipe (|), one record per line:
- Device Problem Code
- Problem Description
DEVICEPROBLEMCODES contains 2 fields, delimited by pipe (|), one record per line:
- MDR Report Key
- Device Problem Code -- (F10) new added; 2006
PATIENTPROBLEMDATA contains following 2 fields, delimited by pipe (|), one record per line:
- Patient Problem Code
- Problem Description
PATIENTPROBLEMCODE contains following 2 fields, delimited by pipe (|), one record per line:
- MDR Report Key
- Patient Problem Code
Device Operator Code Key
- * INVALID DATA
- 0 OTHER
- 1 PHYSICIAN
- 2 NURSE
- 3 NON-HEALTHCARE PROFESSIONAL
- 0HP HEALTH PROFESSIONAL
- 0LP LAY USER/PATIENT
- 100 OTHER HEALTH CARE PROFESSIONAL
- 101 AUDIOLOGIST
- 102 DENTAL HYGIENIST
- 103 DIETICIAN
- 104 EMERGENCY MEDICAL TECHNICIAN
- 105 MEDICAL TECHNOLOGIST
- 106 NUCLEAR MEDICINE TECHNOLOGIST
- 107 OCCUPATIONAL THERAPIST
- 108 PARAMEDIC
- 109 PHARMACIST
- 110 PHLEBOTOMIST
- 111 PHYSICAL THERAPIST
- 112 PHYSICIAN ASSISTANT
- 113 RADIOLOGIC TECHNOLOGIST
- 114 RESPIRATORY THERAPIST
- 115 SPEECH THERAPIST
- 116 DENTIST
- 117 NURSE PRACTIONER
- 300 OTHER CAREGIVERS
- 301 DENTAL ASSISTANT
- 302 HOME HEALTH AIDE
- 303 MEDICAL ASSISTANT
- 304 NURSING ASSISTANT
- 305 PATIENT
- 306 PATIENT FAMILY MEMBER OR FRIEND
- 307 PERSONAL CARE ASSISTANT
- 400 SERVICE AND TESTING PERSONNEL
- 401 BIOMEDICAL ENGINEER
- 402 HOSPITAL SERVICE TECHNICIAN
- 403 MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
- 404 PHYSICIST
- 405 SERVICE PERSONNEL
- 499 DEVICE UNATTENDED
- 500 RISK MANAGER
- 501 ADMINISTRATOR/SUPERVISOR
- 600 ATTORNEY
- 999 UNKNOWN
- NA NOT APPLICABLE
- NI NO INFORMATION
- UNK UNKNOWN
Event Location Code Key
- * INVALID DATA
- 000 OTHER
- 001 HOSPITAL
- 002 HOME
- 003 NURSING HOME
- 004 OUTPATIENT TREATMENT FACILITY
- 005 OUTPATIENT DIAGNOSTIC FACILITY
- 006 AMBULATORY SURGICAL FACILITY
- 500 HOSPITAL
- 501 CATHETERIZATION SUITE
- 502 CRITICAL CARE UNIT
- 503 DIALYSIS UNIT
- 504 EMERGENCY ROOM
- 505 EXAMINATION ROOM
- 506 LABORATORY/PATHOLOGY DEPARTMENT
- 507 MATERNITY WARD - NURSERY
- 508 OPERATING ROOM
- 509 OUTPATIENT CLINIC/SURGERY
- 510 PATIENT'S ROOM OR WARD
- 511 RADIOLOGY DEPARTMENT
- 600 AMBULATORY HEALTH CARE FACILITY
- 601 AMBULATORY SURGICAL CENTER
- 602 BLOOD BANK
- 603 BLOODMOBILE
- 604 CATHETERIZATION LAB - FREE STANDING
- 605 CHEMOTHERAPY CENTER
- 606 CLINIC - WALK IN, OTHER
- 607 DIALYSIS CENTER
- 608 DRUG CLINIC
- 609 IMAGING CENTER - MOBILE
- 610 IMAGING CENTER - STATIONARY
- 611 LABORATORY
- 612 MOBILE HEALTH UNIT
- 613 MRI CENTERS
- 614 PSYCHIATRIC CENTER - WALK IN, OTHER
- 615 TUBERCULOSIS CLINIC
- 616 URGENT CARE CENTER
- 617 OUTPATIENT DIAGNOSTIC FACILITY
- 700 LONG-TERM CARE FACILITY
- 701 HOSPICE
- 702 NURSING HOME
- 703 PSYCHIATRIC FACILITY
- 704 REHABILITATION CENTER
- 705 RETIREMENT HOME
- 810 PATIENT'S HOME
- 820 IN TRANSIT TO USER/MEDICAL FACILITY
- 830 PUBLIC VENUE
- 831 OUTDOORS
- 832 PARK
- 833 PLAYGROUND
- 834 PUBLIC BUILDING
- 835 SCHOOL
- 836 STREET
- 999 UNKNOWN
- NA NOT APPLICABLE
- NI NO INFORMATION
- UNK UNKNOWN
Alternative Summary Reports
On February 18, 2022, the FDA posted the available Patient Problem Codes associated with legacy Alternative Summary Report (ASR) files on FDA.gov. The 2022 update followed the addition of Patient Problem Codes to the public Manufacturer and User Facility Device Experience (MAUDE) database in September 2020 to provide additional information on the nature of adverse events and related devices, when available.
The Alternative Summary Reporting (ASR) Program was in effect from 1997 through June 2019. In June 2019, the FDA formally ended the Alternative Summary Reporting (ASR) Program and revoked all such exemptions. All reports received under ASR exemptions from 1999 to April 2019 (when the FDA last received reports under the ASR program) are available in the legacy data files linked below. Reports received under the ASR Program from 1999 – April 2019 are not available in MAUDE and are therefore provided on this page.
For more information, see the 2019 Statement on agency's efforts to increase transparency in medical device reporting.
By law, manufacturers may request exemptions, variances or alternatives to reporting requirements under 21 CFR 803.19. Under this provision, the FDA had allowed alternative summary reports (ASRs) for specific well-known and well-characterized events associated with specific devices.
It is important to note that data in ASRs are subject to the same limitations as MDR data in the MAUDE database; they are based on the same threshold for reporting and differ in format. This passive reporting system relies on information provided by users of the devices and other sources, and therefore some information about certain events may be missing, inaccurate, or unverified. Manufacturers are responsible for following up to obtain missing information, but it is not always possible to track down details of an event. Therefore, some fields in both the MAUDE database and ASR reports may be blank. Like all MDR data in the MAUDE database, MDR data in ASR reports cannot be used to determine rates of adverse events due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use. In addition, the number of events may fluctuate over time for a variety of reasons that do not reflect a change in the actual rate of the events, such as changes in technology that impact rate of use in clinical practice, changes in a firm's reporting processes, and following a public communication or media reports about a technology. Moreover, the presence of an event or multiple events does not necessarily mean there is a problem with a device. Often additional investigation and data collection are necessary to make that determination.
ASR exemptions excluded events where the device may have caused or contributed to a patient death from being submitted in ASRs, except for sudden death associated with cardiac arrest for certain surgical heart valves when the device had been implanted for at least five years and the event did not necessitate remedial action to prevent an unreasonable risk of substantial harm to the public health.
When an ineligible event was reported through an ASR, the FDA's standard practice was to contact the manufacturer to obtain additional information regarding the event. If the event was labeled in error, the manufacturer was asked to submit a supplemental ASR to correct it. If an event was ineligible for reporting as an ASR, the FDA's standard practice was to require the manufacturer to submit an individual report in MAUDE for the event. In some cases, the FDA revoked ASR exemptions following continued reporting of ineligible events in ASRs.
In some cases, manufacturers also submitted supplemental ASRs providing additional information, such as following an investigation into an event. The supplemental ASRs may include only new information; fields where information did not change from the original ASR may be blank. Both original and supplemental ASRs are posted on our website. Supplemental reports are identified, and caution should be taken so as not to count the same events twice when they appear in both a supplemental and original report.
ASR reports were not made publicly available before 2019 because they were not submitted in a format compatible with the public MAUDE database. The FDA recognized the public interest in this information and modified the conditions of the ASR Program in 2017 to require submission of a companion report on the official mandatory reporting form. The companion report included the total number of events being summarized in the quarterly report through the ASR Program and is available publicly in the MAUDE database. When both an ASR and companion report were submitted, the same events were captured in both systems. Therefore, adding events from ASR and companion reports will result in some double counting.
The following files contain ASR data by reporting year, comprising over six million records in total. Each file is large and contains all ASRs received for that year. As such, these are compressed data files using the zip format. After files are downloaded, they should be unzipped. The unzipped .CSV files can be viewed with a spreadsheet or database software. The ASR data has one record per line, with the data fields in the following comma-delimited format:
Exemption Number,Manufacturer Registration Number,Manufacturer Name,Report ID,Date of Event,Manufacturer Aware Date,Event Type,Device Problem Codes,Report Year,Report Quarter,Initial Report Flag,Device ID,Product Code,Brand Name,Model Number,Catalog Number,Implant Available for Evaluation,Implant Returned to Manufacturer
Following are the compressed MDR data files received from Alternative Summary Reports listed with their compressed and uncompressed file sizes for each year. The data for each year is sorted by product code, exemption number, and quarter.
In February 2022, the FDA added an addendum file containing the Patient Problem Codes for all years of legacy ASR data (1999-2019). The Patient Problem Code records contained in the ASR_PPC file have a one-to-one mapping with the records in the ASR yearly files, based on the Exemption Number, Report ID, Product Code, Report Year, and Report Quarter columns. The ASR_PPC zip file has the same format as the yearly ASR files, with the data fields in the following comma-delimited format: Exemption Number, Report ID, Product Code, Report Year, Report Quarter, Patient Problem Codes. Due to the large size, the addendum file should be opened in database software, such as Microsoft Access, along with the ASR yearly files. This update followed the addition of patient problem codes to the public MAUDE database in September 2020 to provide additional information on the nature of adverse events and related devices, when available.
File name | Compressed Size | Uncompressed Size |
---|---|---|
ASR_1999.zip | 75KB | 1.0MB |
ASR_2000.zip | 0.3MB | 5.7MB |
ASR_2001.zip | 0.5MB | 8.5MB |
ASR_2002.zip | 0.6MB | 10MB |
ASR_2003.zip | 0.7MB | 11MB |
ASR_2004.zip | 0.9MB | 13MB |
ASR_2005.zip | 0.9MB | 14MB |
ASR_2006.zip | 3.3MB | 52MB |
ASR_2007.zip | 3.5MB | 54MB |
ASR_2008.zip | 3.3MB | 51MB |
ASR_2009.zip | 3.6MB | 55MB |
ASR_2010.zip | 3.5MB | 53MB |
ASR_2011.zip | 3.4MB | 52MB |
ASR_2012.zip | 3.8MB | 57MB |
ASR_2013.zip | 3.7MB | 55MB |
ASR_2014.zip | 3.8MB | 56MB |
ASR_2015.zip | 3.9MB | 56MB |
ASR_2016.zip | 4.5MB | 68MB |
ASR_2017.zip | 3.8MB | 55MB |
ASR_2018.zip | 1.5MB | 23MB |
ASR_2019.zip | 83KB | 0.9MB |
ASR_PPC.zip | 16MB | 279MB |
ASR Data File Values
The below table describes data elements and information contained in the data files. Some fields in some reports may contain blanks or "?" in circumstances where a manufacturer did not have a particular piece of information, the report was supplemental and the information had already been reported, or due to limitations on the text encoding that was accepted when creating the data files. Some reports for silicone-filled breast implants include additional data fields, as required by the FDA as a condition of their summary reporting exemption.
Data Element | Column Heading | Description |
---|---|---|
Exemption Number | exemptn_no | The exemption ID number from the ASR approval letter |
Manufacturer Registration Number | mfr_no | CFN or FEI belonging to the reporting firm |
Manufacturer Name | mfr_name | Reporting firm name, analogous to G1 Manufacturer Name on the 3500A form |
Report ID | report_id | Unique identifier for this ASR report. Duplicate values from the same firm in this field indicate initial and supplement reports. Analogous to G9 Manufacturer Report Number on the 3500A form. |
Date of Event* | date_of_event | The date of the adverse event. Analogous to B3 Date of Event on the 3500A form. |
Manufacturer Aware Date | mfr_aware_date | The date the manufacturer became aware of the adverse event. Analogous to G4 Date Received by Manufacturer on the 3500A form |
Event Type | event_type | The type of adverse event, analogous to H1 Type of Reportable Event on the 3500A form. The expected values are: M=Malfunction M-D=Malfunction where a patient death was reported IN=Serious Injury IN-D=Serious Injury where a patient death was reported D=Death |
Device Problem Codes | dev_prob_cd | A semicolon-delimited list of Device Problem Codes describing the adverse event. Analogous to H6 Device Code on the 3500A form. For the list of expected values and what they mean, see: ASR DPC Terms.csv |
Report Year | report_year | The submission year for this report |
Report Quarter | report_qtr | The submission quarter for this report |
Initial Report Flag | initial_report_flag | A flag indicating whether the report is an initial or supplement, analogous to G7 Initial/Follow-up on the 3500A form. Note that this field was not provided by the submitter, but rather derived by FDA for ease of data analysis. The expected values are: I=Initial S=Supplement |
Device ID | dev_id | The identifier key for the device in the ASR database, typically a model number or catalog number. |
Product Code | product_code | The product code of the device. Analogous to D2 Procode on the 3500A form. |
Brand Name | brand_name | The brand name of the device. Analogous to D1 Brand Name on the 3500A form. |
Model Number | model_no | The model number of the device. Analogous to D4 Model Number on the 3500A form. |
Catalog Number | catalog_no | The catalog number of the device. Analogous to D4 Catalog Number on the 3500A form. |
Implant Available for Evaluation* | impl_avail_for_eval | Flag indicating whether the device is available for evaluation. Analogous to D10 Device Available for Evaluation Yes/No on the 3500A form. The expected values are: 1=Yes 2=No 7=No Information |
Implant Returned to Manufacturer* | impl_ret_to_mfr | Flag indicating whether the device was returned to the manufacturer. Analogous to the Returned to Manufacturer checkbox under D10 on the 3500A form. The expected values are: 1=Yes 2=No |
Patient Problem Codes** | pat_prob_cd | A semicolon-delimited list of Patient Problem Codes describing the adverse event. Analogous to H6 Patient Code on the 3500A form. For the list of expected values and what they mean, see: ASR PPC Terms.csv |
* Field required only for some reports for silicone-filled breast implants as a condition of their summary reporting exemption.
** The Patient Problem Code data element is only available in the ASR_PPCs zip file.
Device Experience Network (DEN) Reports
CDRH's Device Experience Network (DEN) was used by the FDA from 1984 – 1996 to store file reports received under both the mandatory Medical Device Reporting Program (MDR) from 1984 - 1996, and the voluntary reports up to June 1993. These files contain over 600,000 reports.
An on-line search is available which allows you to search for information on medical devices which may have malfunctioned or caused a death or serious injury during the years 1984 through 1996.
The following files contain DEN data listed by the year they were received. Each file is large, and complete for that year. As such, these are compressed data files using the zip format. After files are downloaded, they should be unzipped. The unzipped .TXT files can be viewed with a text editor, spreadsheet or database software. The MDR data has one record per line, with the data fields in the following pipe-delimited, (i.e., "|") format:
Access Type and Number|Date Received|Product Description|Manufacturer name code|Manufacturer Name|Street address|City|State
|Zipcode|Report type|Model number|Catalog number| FDA panel code|FDA Product code|Event description type|Event description|Closeout text
Following are the compressed MDR data files received from CDRH's DEN reports listed with their compressed and uncompressed file sizes. The last file listed, disclaim.zip, contains a disclaimer from the manufacturer for each report.
File name | Compressed Size | Uncompressed Size |
---|---|---|
mdr84.zip | 24KB | 78KB |
mdr85.zip | 1.7MB | 10MB |
mdr86.zip | 2.2MB | 13MB |
mdr87.zip | 2.0MB | 12MB |
mdr88.zip | 1.9MB | 11MB |
mdr89.zip | 2.2MB | 14MB |
mdr90.zip | 3.2MB | 18MB |
mdr91.zip | 5.0MB | 30MB |
mdr92.zip | 7.3MB | 49MB |
mdr93.zip | 8.5MB | 56MB |
mdr94.zip | 8.5MB | 63MB |
mdr95.zip | 8.6MB | 47MB |
mdr96.zip | 8.5MB | 42MB |
mdr97.zip | 11.0KB | 45KB |
disclaim.zip | 163KB | 2MB |