maude

is a Data Source.

The U.S. FDA database of medical device adverse event reports. It houses mandatory reports submitted by device manufacturers, importers, and device user facilities, along with voluntary reports from healthcare professionals, patients, and consumers. The data are searchable through a public web interface and are also released as downloadable data files and via an API.

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Repository

Unknown

External IDs

No external IDs available

Product Summary

Contacts

U.S. Food and Drug Administration, Center for Devices and Radiological Health

URL: https://www.fda.gov/about-fda/fda-organization/center-devices-and-radiological-health

Products

From this Resource

ID	Name	URL	Category	Format	Description
maude.data	MAUDE Database and Downloadable Data Files	event	Product	http	The MAUDE medical device adverse even...

From other Resources

ID	Name	URL	Category	Format	Relation	Description
maudekg.graph	FDA MAUDE Adverse Event Knowledge Graph	maudekg	Graph	ttl	was derived from	RDF knowledge graph constructed from ...
openfda.apis	openFDA APIs	apis	Programming Interface	http	had primary source	JSON REST APIs (Elasticsearch query s...
openfda.downloads	openFDA Bulk Downloads	downloads	Product	json	had primary source	Bulk downloads of every openFDA endpo...

Details

MAUDE (Manufacturer and User Facility Device Experience)

Description

MAUDE is the U.S. Food and Drug Administration’s database of medical device adverse event reports. It captures mandatory reports from device manufacturers, importers, and device user facilities, together with voluntary reports from healthcare professionals, patients, and consumers.

The database supports post-market surveillance of medical devices by documenting suspected device-associated deaths, serious injuries, and malfunctions. Records are searchable through the FDA’s public web interface and are also distributed as downloadable data files and through the openFDA device adverse event API.