Replicating the FDA MAUDE DB for September 2021 in order to search MDR summaries as well as create custom insights. Required downloading files from the FDA, using python to confirm data structure, and upload to database tables. WAMP stack used to access data/provide charts.

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.

13. Cobalt Patient Outcomes

14. Cobalt Event Types

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.