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MAUDE (Manufacturer and User Facility Device Experience)

Metadata Updated: July 11, 2025

MAUDE data represents reports of adverse events involving medical devices. The data consists of all voluntary reports since June, 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August, 1996.

Access & Use Information

Public: This dataset is intended for public access and use. License: See this page for license information.

Downloads & Resources

References

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/ucm127891.htm

Dates

Metadata Created Date November 10, 2020
Metadata Updated Date July 11, 2025

Metadata Source

Harvested from Healthdata.gov

Additional Metadata

Resource Type Dataset
Metadata Created Date November 10, 2020
Metadata Updated Date July 11, 2025
Publisher U.S. Food and Drug Administration
Maintainer
Identifier 1327f116-da9f-40b9-babd-c893ab2ceacd
Data First Published 2021-02-25
Data Last Modified 2013-10-31
Category FDA
Public Access Level public
Bureau Code 009:10
Metadata Context https://project-open-data.cio.gov/v1.1/schema/catalog.jsonld
Metadata Catalog ID https://healthdata.gov/data.json
Schema Version https://project-open-data.cio.gov/v1.1/schema
Catalog Describedby https://project-open-data.cio.gov/v1.1/schema/catalog.json
Harvest Object Id 863276aa-256c-4751-aed2-060437d6f345
Harvest Source Id 651e43b2-321c-4e4c-b86a-835cfc342cb0
Harvest Source Title Healthdata.gov
Homepage URL http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM
License http://opendefinition.org/licenses/odc-odbl/
Program Code 009:005
Related Documents http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/ucm127891.htm
Source Datajson Identifier True
Source Hash 154760dd10d047599864cebf7da935816a915118911d288f20dd10223af81764
Source Schema Version 1.1
Temporal 1991-01-01/2013-10-31

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