Maude search fda

• [DOC File]Novel Technologies for Patient-Controlled Analgesia

  https://info.5y1.org/maude-search-fda_1_58bcbe.html

  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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• Sharps Injuries among Hospital Workers in Massachusetts, 2005

  The Manufacturer and User Facility Device Experience Database (MAUDE) contains reports of adverse events involving medical devices, which were sent to the FDA. [MAUDE, p1] Of 2,000 reports, 4.4% (88/2,000) were documented as “under-delivery” of analgesia.

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• [DOC File]Methodology - Vanderbilt University

  https://info.5y1.org/maude-search-fda_1_8aaff9.html

  Additionally, the safety databases MAUDE at the FDA and “Maßnahmen von Herstellern” at the BfArM are searched for product specific reports from manufacturers. For identification of background data and data on the state-of-the-art, distinct searches are carried out.

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• [DOC File]GHTF SG5 Clinical Evaluation - IMDRF

  https://info.5y1.org/maude-search-fda_1_d35ede.html

  Jan 20, 2021 · Artificial Intelligence, the mathematical expression of human intelligence to engineer expert systems, software as a medical device, and adaptive statistical models used to optimize device performance (FDA, 2019.; McCarthy 2007), encompasses the algorithm platforms of …

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• [DOC File]Surgical Mesh Repairs 2011 - Cape Gynecology

  https://info.5y1.org/maude-search-fda_1_eae2a4.html

  It is preferable that certificates of conformity in other regulatory jurisdictions (e.g. CE marking, FDA, Health Canada) be provided including the number and date of issue of international certificates, as these allow verification of post-market data (e.g. through search of FDA’s Manufacturer and User Facility Device Experience (MAUDE)), and ...

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• [DOCX File]Clinical evidence guidelines: Medical devices

  https://info.5y1.org/maude-search-fda_1_785405.html

  Our current product research also included a search of the FDA’s Manufacturer and User Facility Device Experience Database - (MAUDE) in order to review any reports of adverse events that had been submitted involving the KCI V.A.C. device. We found no cases where there …

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• [DOCX File]Clinical Evaluation Report | Number one source for ...

  https://info.5y1.org/maude-search-fda_1_03d751.html

  Certificates of conformity in other regulatory jurisdictions (e.g. CE marking, FDA, Health Canada should be provided including the number and date of issue of international certificates as these provide a useful tool to verify data and to search databases for adverse events, e.g. FDA’s Manufacturer and User Facility Device Experience (MAUDE)).

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• [DOCX File]Consultation: Draft clinical evidence guidelines - Medical ...

  https://info.5y1.org/maude-search-fda_1_989bf6.html

  Search engines such as Yahoo and Hotbot are readily available, but search engines that utilize multiple other search engines, such as GO Network Express Search engine are far more useful. ... 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 ...

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• [DOC File]Software Aids for Biomedical Engineering Design Courses

  https://info.5y1.org/maude-search-fda_1_082f8d.html

  adverse event report databases (e.g. MAUDE, IRIS) reference texts [Include justification for choice of sources and describe any supplemental strategies (eg checking bibliography of articles retrieved, hand searching of literature) used to enhance the sensitivity of the search] Database search details

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• Does the FDA's MAUDE Work? - Mesh Medical Device News Desk

  Experience with a device is then visible to others who search the database. This can be useful when: Alternative devices are being considered and information about any “red flags” to be aware of is being researched. Searching the FDA’s MAUDE database (see below) might provide comments or information about injuries from other users of the ...

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