Introduction to the MAUDE Database
- 1 March 2008
- journal article
- review article
- Published by Ovid Technologies (Wolters Kluwer Health) in Clinical Obstetrics and Gynecology
- Vol. 51 (1), 120-123
- https://doi.org/10.1097/grf.0b013e318161e657
Abstract
The Manufacturer and User Facility Device Experience (MAUDE) database represents a reporting system mandated by the Food and Drug Administration for postmarket surveillance. MAUDE has been made into a searchable online database that includes all reported events in which medical devices may have malfunctioned or caused a death or serious injury. For the clinician considering the use of a new medical device, searching the MAUDE database is useful to search for complications not yet reported in the medical literature.Keywords
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