FDA MAUDE DB Text Search Insights
- 1. FDA MAUDE Data Insights Trevor Schmaeling
- 2. MAUDE DataBase Introduction “MAUDE data represents reports of adverse events involving medical devices. The download data files consist of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. The searchable database data contains the last 10 year's data. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19.”(FDA)
- 3. Project Background • Project started since I wanted to be able to find my own custom statistics on the MAUDE DB. A lot of statistics are difficult to come by, especially on a DB that receives little attention from the general public. • Information I provide is based on September 2021. • First step was to use the https://open.fda.gov/ API. However, at the time I used it, the data provided was not up to date (most recent month). • The next step I took was to download the data directly from the FDA.
- 4. Collection of Data (1/2)
- 5. Collection of Data (2/2)
- 6. Check Data Structure, Then Add to DB
- 7. Example of what a Table Looks Like 151K+ rows just for 1 month
- 8. This is the Same Table Zoomed Out
- 9. Search Through Text for “cobalt” To access the DB I created a basic search interface.
- 10. Advanced Search is also an Option More fields such as “Date” can also be added
- 11. Some Provided Results for “cobalt”
- 12. Cobalt Device Problems Each “Device Code” corresponds to an actual name in text. I could have done a UNION sql search however the time it takes to receive results is not worth it. Will be updated by changing the code to text before displaying the graph.
- 15. Search Through Text for “allergic reaction”
- 16. Some Provided Results for “allergic reaction”
- 17. Allergic Reaction Device Problems
- 18. Allergic Reaction Patient Outcomes
- 19. Allergic Reaction Event Types
- 20. Conclusions • Being able to search through MDR Summaries is a valuable tool for providing specific analysis. • Visually seeing the provided Device Problems, Patient Outcomes, and Event Types data of a keyword in an MDR summary can assist in root problem(s) diagnostics. • Although the MAUDE DB data is not 100% verified, the noise can be reduced through (eventual) further in-depth queries, as well as by looking at the trend.
- 21. FDA Provided MAUDE Warnings • Please note that the MAUDE web search feature is limited to adverse event reports within the past 10 years. • MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices. • Confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report. Establishing a cause-and-effect relationship is especially difficult if circumstances surrounding the event have not been verified or if the device in question has not been directly evaluated. • MAUDE data does not represent all known safety information for a reported medical device and should be interpreted in the context of other available information when making device-related or treatment decisions. • Variations in trade, product, and company names affect search results. Searches only retrieve records that contain the search term(s) provided by the requester. • Submission of a medical device report and the FDA's release of that information is not necessarily an admission that a product, user facility, importer, distributor, manufacturer, or medical personnel caused or contributed to the event. • Certain types of report information are protected from public disclosure under the Freedom of Information Act (FOIA). If a report contains trade secret or confidential business information, that text is replaced by "(b)(4)". If a report contains personnel or medical files information, that text is replaced by "(b)(6)". The designations "(b)(4)" and "(b)(6)" refer to the exemptions in the FOIA. For example, "(b)(4)" may be found in place of the product's composition and "(b)(6)" may be found in place of a patient's age. • MAUDE is updated monthly and the search page reflects the date of the most recent update. The FDA seeks to include all reports received prior to the update but the inclusion of some reports may be delayed.