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Sep 30, 2024 · The MAUDE database contains adverse event reports of medical devices submitted to the FDA by mandatory and voluntary reporters. Users can search the database by simple or advanced options, or download MDR files from the FDA website.
- Registration & Listing
Registration & Listing - Manufacturer and User Facility...
- Standards
This database provides the most up-to-date list of voluntary...
- Postmarket Surveillance Studies
522 Postmarket Surveillance Studies Database. FDA Home;...
- Recalls
This database contains Medical Device Recalls classified...
- CLIA
CLIA - Manufacturer and User Facility Device Experience...
- Medsun Reports
While data prior to July 2024 is still accessible, the...
- MDR Data Files Webpage
Therefore, some fields in both the MAUDE database and ASR...
- FDA Guidance Documents
The table below lists all official FDA Guidance Documents...
- Registration & Listing
Jun 6, 2024 · The MAUDE database contains adverse event reports of medical devices submitted by manufacturers, importers, and user facilities. Learn about the database description, limitations, fields, and how to access the data files and disclaimers.
MAUDE contains reports of suspected device-associated deaths, serious injuries and malfunctions submitted by manufacturers, importers, device user facilities and others. The FDA uses MAUDE to monitor device performance, detect safety issues and contribute to benefit-risk assessments.
The Maude Database, short for Manufacturer and User Facility Device Experience, is a publicly accessible database maintained by the U.S. Food and Drug Administration (FDA). It serves as a repository for reports of adverse events and product problems associated with medical devices.
Apr 24, 2023 · The Manufacturer and User Facility Device Experience (MAUDE) database is an online searchable and publicly accessible repository developed by the United States Food and Drug Administration (FDA) for systematic data collection of adverse outcomes related to the medical devices.[2][3]
Jun 14, 2017 · The US Food and Drug Administration (FDA)’s Manufacturer and User Facility Device Experience (MAUDE) database is a publicly available resource providing over 4 million records relating to medical device safety. Using downloadable MAUDE files avoids limitations of the online MAUDE search interface.
Our search engine for the MAUDE database allows users to apply search criteria such as device type, catalog number, and lot number. It also permits more complex search strategies (for greater search flexibility) and more user-friendly search results, including the ability to save or print all results from a single page.
