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Introduction to the MAUDE Database

GURTCHEFF, SHAWN E. MD

Clinical Obstetrics & Gynecology:
doi: 10.1097/GRF.0b013e318161e657
New Technology in Gynecology
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.

Author Information

Department of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, Utah

Correspondence: Shawn E. Gurtcheff, MD, Department of Obstetrics and Gynecology, Suite 2B200, University of Utah Health Sciences Center, 30 North 1900 East, Salt Lake City, UT. E-mail: shawn.gurtcheff@hsc.utah.edu

© 2008 Lippincott Williams & Wilkins, Inc.