title: Introduction to the MAUDE database.
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.
authors.affiliation: Department of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, Utah, USA. shawn.gurtcheff@hsc.utah.edu
authors.forename: Shawn E
authors.initials: SE
authors.lastname: Gurtcheff
mesh_terms: D019992:Databases as Topic; D005260:Female; D013509:Gynecologic Surgical Procedures / Q000009:adverse effects* / Q000295:instrumentation*; D006801:Humans; D011358:Product Surveillance, Postmarketing; D014481:United States; D014486:United States Food and Drug Administration