How to Search the FDA MAUDE Database for Medical Device Adverse Events
Use a free MAUDE search to find adverse event reports by product, manufacturer, or product code, then connect them to recalls and other FDA records.
Search FDA medical device adverse event reports by product, company, or product code
Search the reports before asking AI to summarize them
The FDA MAUDE database contains medical device reports submitted to FDA. The useful first step is retrieval: find the reports that match the product, company, brand, model, or product code you are investigating. The FDA MAUDE Safety Reports tool provides that search surface and keeps each result connected to its underlying report.
Open the tool above and start with the most specific identifier or name you have. Broaden only after you understand what the first result set contains.
Choose a search strategy
| Starting information | Search approach |
|---|---|
| Product code | Use it to collect reports in the same FDA device category |
| Manufacturer | Try the legal name and verified historical or punctuation variants |
| Brand or model | Search the distinctive term, then check manufacturer and device fields |
| Event question | Filter or inspect event type, date, and narrative fields |
A company-name search can miss reports filed under a former name or variant. A product-code search can be broader than one commercial device. Use both when you need a more complete view, and preserve the exact query that produced each result set.
Read MAUDE as report data, not an incidence rate
MAUDE is valuable for detecting report patterns and finding case narratives, but the number of reports is not the rate of occurrence. Reporting practices, follow-up, duplicate reports, incomplete information, device exposure, and verification can differ. A report also does not by itself establish that a device caused the event.
That means a useful analysis states what was observed in the retrieved reports and avoids claims the dataset cannot support. Compare like with like, describe the search window, and keep duplicates or linked follow-ups in mind.
Inspect the record before grouping it
Open representative reports and examine the device identity, manufacturer, event type, dates, narrative, and any available follow-up. Product family names can be broad, while a narrative may contain the model or procedure detail needed to decide whether the report belongs in your analysis.
When AI is used to group themes, retain links to the included reports. A theme such as breakage, false result, alarm failure, or use error is only useful when a reviewer can reopen the records that produced it.
Connect MAUDE to other FDA tools
| Question | Next tool |
|---|---|
| Was a corrective action or removal announced? | FDA Medical Device Recalls |
| What classification and pathway use this product code? | FDA TPLC Intelligence |
| Which labeled models or identifiers are associated with the device? | FDA GUDID / UDI Lookup |
| What premarket and market records exist in the category? | FDA TPLC Intelligence |
These sources answer different questions. A recall is not the same thing as an adverse event report, and a UDI record is not a safety conclusion. Their value comes from being connected without being collapsed into one type of evidence.
Turn a result set into a repeatable safety review
Save the product terms, company names, product codes, filters, and cutoff date used in the search. Then summarize counts and themes with the search boundary beside them. If the review will be repeated, use the same baseline and record what changed rather than rebuilding an untraceable result set.
A quick quality check
Before relying on the analysis, confirm that:
- the exact queries and date range are recorded;
- company-name variants are evidence-backed;
- sampled narratives actually relate to the device being studied;
- follow-ups and possible duplicates are considered;
- report counts are not presented as incidence or proof of causation;
- every summarized theme links back to its source reports;
- recalls, GUDID, and premarket records remain clearly labeled as separate datasets.
The tool is useful because it gets you into the safety records quickly. The connected FDA tools then help place those reports in the product category and market context without overstating what MAUDE can prove.
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