2008
DOI: 10.1097/grf.0b013e318161e657
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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 litera… Show more

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Cited by 68 publications
(68 citation statements)
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“…24 The FDA MAUDE database can be a valuable tool to obtain device-related information; however, the device reports often lack essential details to determine the cause of the event. 25 After a thorough review of all adverse events (deaths and injuries) related to CORTRAK-assisted insertion of feeding tubes, we recommend that health care providers include the following additional information in the required fields to improve the quality of these reports:…”
Section: Recommendations For Adverse Events Reportingmentioning
confidence: 99%
“…24 The FDA MAUDE database can be a valuable tool to obtain device-related information; however, the device reports often lack essential details to determine the cause of the event. 25 After a thorough review of all adverse events (deaths and injuries) related to CORTRAK-assisted insertion of feeding tubes, we recommend that health care providers include the following additional information in the required fields to improve the quality of these reports:…”
Section: Recommendations For Adverse Events Reportingmentioning
confidence: 99%
“…An internet search using "TVT Secur" and "class action" identifies many legal groups who aim to bring class action suits representing women who feel they have been harmed by the device. The US MAUDE Medical Device Reports database [112] provides further insight: between January 2006 and November 2014, the database includes 1655 entries for TVT Secur mainly related to injury. The vast majority of reports (1546 (93%)) were made in the months of June to December 2013, following the removal of TVT Secur from the device market.…”
Section: Discussionmentioning
confidence: 99%
“…As such, newer meshes have been introduced as 510(K) devices with minimal premarket testing, where manufacturers must only demonstrate substantial equivalence to a 'predicate devices' [23]. Manufacturers only needed to show that a new mesh had the same use and similar characteristics and was theoretically as safe and effective as the predicate device.…”
Section: Fda Warningmentioning
confidence: 99%
“…The notification stated that more than 1000 reports of various complications were received from nine manufacturers in a 3-year period via the Manufacturer and User Facility Device Experience (MAUDE) database [24]. The MAUDE database was created to compile information regarding devicerelated death, serious injury, or malfunctions from manufacturers (report required within 30 days of becoming aware of the event) or hospitals, treatment facilities, nursing homes and ambulatory surgical facilities (report required within 10 business days of becoming aware of the event) [23]. The FDA subsequently issued an update to their original notification in July 2011 reporting an additional 1503 events recorded from 1 January 2008 to December 2010 with POPtype mesh repair [101].…”
Section: Fda Warningmentioning
confidence: 99%