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MAUDE - Manufacturer and User Facility Device Experience
Jan 31, 2021 · The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters 1 (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.
maude database medical device

[DOC File]Software Aids for Biomedical Engineering Design Courses
https://info.5y1.org/maude-database_1_082f8d.html
The group effort required students to investigate a device failure, as reported in the FDA database MAUDE, which resulted in a death. Students were to analyze the device and report on the failure mode, and suggest means of correction of the failure. Devices studied included bed side rails, oxygen regulators, pacemakers, and glucose test strips. ...
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[DOC File]BME272 Final Exam - Research
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4. What is the FDA mandated MAUDE database? How is it populated? What federal act requires this information to be posted? 5. What is the purpose of the Health Insurance Portability and Accountability Act (HIPAA)? What are the penalties for disobeying the act? 6. What does the “voice of the customer” involve? Give a brief example diagram. 7.
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[DOCX File]24fc4y3daje01qkvkm3oo1ao-wpengine.netdna-ssl.com
https://info.5y1.org/maude-database_1_8ecb42.html
Also, the FDA's MAUDE Database is terrible and never current with what is really going on with device and drug complications). At least 56 of these patients lacked a gallbladder and received the recommended dose of the drug for patients without a gallbladder. 76 …
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Sharps Injuries among Hospital Workers in Massachusetts, 2005
Searching the FDA’s MAUDE database (see below) might provide comments or information about injuries from other users of the device. There has been a negative experience with a device and in deciding how to respond, it’s helpful to know if others are having a …
fda's maude database

[DOCX File]Oxygen (Compressed Gas) Cylinder Hazard Summary
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FDA's MAUDE Database -- Case study from searching on "CO2 Cylinder" Report Date: 07/20/1999MDR Text Key: 783215Patient Sequence Number: 1. At approximately 12:30 pm, July 12, 1999, a vascular shut was placed in a pt. for the purpose of dialysis. The procedure was successful and the pt. was prepared to return to the nursing unit.
fda maude database adverse events

[DOC File]Surgical Mesh Repairs 2011 - Cape Gynecology
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The FDA conducted a search of the Manufacturer and User Device Experience (MAUDE) database for medical device reports (MDRs) of adverse events associated with all urogynecologic surgical mesh products received from January 1, 2005 - December 31, 2010. The search identified 3,979 reports of injury, death, and malfunction.
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[DOCX File]Nurse Maude Association - Nurse Maude Hospital
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There is a central electronic database (Client Management System) held in the main office of Nurse Maude that records the consumer’s key information (name, address etc) and automatically generates and allocates an unique identifier. The NHI number once known is added to the database and is able to be searched by either identifier.
maude reports

[DOC File]University of Chicago
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We explored two avenues in computational language processing to facilitate the automatic identification of “interesting” medical incident reports from the MAUDE database. One approach employed statistical n-gram language modeling to identify and characterize incident reports.
maude database medical device

[DOCX File]MR Hazard Summary - Veterans Affairs
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MR events in the public press and FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. The fact that MR hazards are complex and not obvious. The increasing amount of procedures and even surgeries performed within MR suites. MR systems with more powerful magnets being marketed to facilities. Limitations:
fda maude data

Maude database