MAUDE database guide to searching FDA device event reports
Search the FDA MAUDE database for reported device problems. Learn how to check identifiers, read reports and avoid treating counts as device safety rates.
The FDA MAUDE database contains medical device reports of adverse events. Use it to investigate reported device problems, not to calculate complication rates or establish that a device caused harm. MAUDE stands for Manufacturer and User Facility Device Experience. FDA's overview explains its contents and limits.
For a useful search, identify the device first. Then read the reports behind the results and record what you searched. A result count alone cannot answer whether one device is safer than another.
What FDA MAUDE reports contain
MAUDE includes reports from manufacturers, importers and device user facilities, whose mandatory reporting duties differ. Health professionals, patients, caregivers and consumers can also report voluntarily. FDA uses medical device reporting, or MDR, for postmarket surveillance and to detect potential safety issues. FDA's MDR guidance describes these reporting routes.
A record can contain device identifiers, an event description, a manufacturer narrative and device or patient problem codes. Missing information may leave fields absent. FDA displays the most recent MDR information, so follow-up submissions can add details to a record. FDA documents these fields and updates.
How to approach a MAUDE database search
Start at the FDA MAUDE search page. The steps below are a review method, not a click-by-click tour or an FDA-required procedure.
Prepare the device identifiers
Write down the brand and manufacturer, plus the model, catalog number or UDI where available. Include the product code if you know it. FDA defines the brand name as the trade or proprietary name on the label or in the catalog. Its field definitions also cover product code, model, lot and UDI information.
Use the available search options to investigate those identifiers. Don't rely on a name match alone. Check the returned device details against the device you meant to investigate, and record each variation you searched.
Define the period and check the dates
Choose the period and event categories relevant to your review. FDA's reportable-event field includes death, serious injury and malfunction. But a report has several dates with different meanings:
| Date in the report | What it means |
|---|---|
| Date of Event | Actual or best-estimate event onset |
| Initial Report FDA Received Date | Initial receipt by FDA, unchanged by supplements |
| Report Date, Section B | Submission date, showing the latest follow-up submission where applicable |
Use FDA's field definitions to distinguish these dates. Check which date the search uses before interpreting results. A receipt date is not the event date.
Read and save the underlying records
Read the event description alongside the manufacturer narrative. Compare identifiers and problem codes before deciding whether a record belongs in your review. Keep the MDR Report Key, search date and search criteria in your working file.
The MDR Report Key stays unchanged when follow-ups arrive. Save the details used in your assessment, rather than assuming a later visit will show identical content. FDA explains the key and follow-up handling in its MAUDE documentation.
Online coverage and historical MAUDE data
FDA's published overview describes the online database as containing the last ten years of MDR data. It says updates occur monthly, covering reports received through the previous month's last day. Check FDA's current search page for the dates available to your review. Some reports under exemptions, variances or alternative reporting requirements before June 2019 may be absent. See FDA's coverage notes.
For older or broader research, use the official MDR data files. Their coverage includes:
- User-facility reports since 1991.
- Distributor reports since 1993 and voluntary reports since June 1993.
- Manufacturer reports since August 1996.
The monthly ZIP files separate master/event, device, patient, narrative and problem-code records. Join the record types you need using MDR REPORT KEY. Broader historical coverage does not remove the reporting limitations.
The download page announces planned availability of MAUDE data in FDA's Adverse Event Monitoring System (AEMS) in 2026. Follow FDA's current links for access and transition updates.
What a MAUDE report cannot tell you
A filed report does not prove that a device caused or contributed to an outcome. FDA's reporting guidance states this explicitly.
Keep these limits beside any findings:
- Counts are not rates. MAUDE lacks the device-use information needed for a denominator. FDA says it cannot establish incidence, prevalence or cause alone, or compare adverse-event rates between devices.
- Rows are not necessarily unique events. Different sources can report the same event. Multiple devices can appear separately in results, and summary reports can describe multiple events.
- Details can remain incomplete. Information may be missing, inaccurate or unverified. Public records may also contain redactions for confidential business or protected personal information.
- An empty search is not a safety verdict. Underreporting and incomplete information prevent that conclusion.
FDA sets out these limits in its MAUDE overview and download documentation. Keep conclusions tied to the reported problem, rather than ranking devices by raw totals.
Searching is separate from reporting
RegAffairs AI has a worked answer on MAUDE search and its limits.
To submit a device problem, use FDA's MDR reporting guidance, not the search form. It provides mandatory reporting instructions and Form 3500A, plus voluntary MedWatch routes and Form 3500.