Regulatory topic
FDA MAUDE: medical device adverse event reports, summarised
MAUDE is the FDA's database of reports about suspected device-related deaths, serious injuries and malfunctions. MedTech Signal turns it into monthly trends by device type and by company, each linked to the FDA's own records.
Who files the reports
Manufacturers, importers and user facilities such as hospitals must report certain events; patients, clinicians and others may report voluntarily. Each report describes the event, the device and the problem codes assigned.
Limits you need to know
A report is not proof that a device caused an event. Reports can be incomplete, duplicated, or filed months later, and reporting rises after publicity or a recall. Fewer reports never means a device is safe — we show 'No reports found in the FDA database', nothing stronger.
What MedTech Signal shows
Five years of monthly report counts split into deaths, injuries and malfunctions, for the highest-volume device types (FDA product codes) and manufacturers, plus the most common reported problems. The latest 20 reports for any of them are fetched live from the FDA, each linking to the FDA record. Company links to our FDA, Health Canada, EU and UK records are shown as possible matches.
Who uses this
Post-market surveillance teams benchmarking their devices against the device type, product liability lawyers reviewing a company's report history, due-diligence teams, and hospitals and purchasing groups checking a supplier.
Held: monthly MAUDE report counts for the last 5 years for roughly the top 1,000 FDA product codes and top 1,000 manufacturers by report volume, refreshed weekly. Not held: individual report text (fetched live on request). Source: open.fda.gov device adverse events and accessdata.fda.gov MAUDE.