The FDA makes medical device reports available to patients and health care providers on the FDA's public Manufacturer and User Facility Device Experience (MAUDE) database as one source of information to help them make more informed medical decisions. However, there are certain cases in which such information was not included in MAUDE. Older reports received through CDRH's legacy Device Experience Network (DEN) reporting system from 1984 – 1996 and reports received under the Alternative Summary Reporting Program from 1999 – April 2019 are not available in MAUDE and are therefore provided on this page.
Please note that the FDA is required under the Freedom of Information and Privacy Acts (SEC 552, Title 5, USC) (PL 93-579) 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.
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On February 18, 2022, the FDA posted the available Patient Problem Codes associated with legacy Alternative Summary Report (ASR) files on FDA.gov. This update follows 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 Alternative Summary Reporting 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 MAUDE; 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 MAUDE and ASR reports may be blank. Like all MDR data in MAUDE, 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 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-D=Malfunction where a patient death was reported
IN-D=Serious Injury where a patient death was reported
|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:
|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:
|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:
|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|
The files provided below contain information from CDRH's Device Experience Network (DEN) reports on devices which may have malfunctioned or caused a death or serious injury. The DEN files below contain information from a former CDRH database that was replaced by the MAUDE database in 1996. The files contain 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 the MDR database 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 broken out 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|