What FDA Adverse Event Reports (MAUDE) Can and Can't Tell You
Last reviewed Oct 16, 2026 · Based on FDA sources listed below · Editorial policy
The FDA's MAUDE database holds millions of reports about problems with medical devices. It is the main public record of what goes wrong with devices in real-world use — but it is easy to misread.
What a report is
A report describes an event in which a device may have caused or contributed to a death or serious injury, or a malfunction that could cause harm. Reports come from manufacturers, importers, hospitals, health professionals and patients.
What reports can tell you
- What kinds of problems are reported for a device — the device problem and patient problem terms show what comes up most often.
- How problems were described by the people involved, in their own words.
- Questions worth asking. A cluster of similar reports can be a reason to ask your healthcare provider or the manufacturer about a problem.
What reports can't tell you
- Whether the device caused the event. A report is not a verified finding, and many devices are never examined.
- How often a device fails. The FDA notes that the number of devices in use is unknown, so reports can't be turned into failure rates. A thousand reports for a device used by millions may mean far less than fifty for a rarely used one.
- Whether reporting is rising for a real reason. The FDA advises against using report counts to judge changes over time, because reporting itself changes — after news coverage, a recall or a new reporting program.
- Which device is safer. Report counts should not be used to compare products.
- The complete picture. MAUDE is a passive system: many events are never reported, and some reports are incomplete or inaccurate.
How to use this site's numbers
Use reports to understand what has been reported for your device and to prepare questions for your healthcare provider — not as a safety score. Our methodology page explains exactly how reports are linked to each device, and why our counts are lower than MAUDE's total.
This guide explains public FDA information. It is not medical advice — talk to your healthcare provider about decisions involving your device.