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[DOC File]Novel Technologies for Patient-Controlled Analgesia
https://info.5y1.org/fda-maude-data_1_58bcbe.html
MAUDE data represents reports of adverse events involving medical devices. Examples of some of the complaints include necessary device removal due to urethra erosion, need for re-implantation because of a leaky implant, device malfunction, improper fitting of cuff due to urethral atrophy and tubing erosion.
fda maude database adverse events

Sharps Injuries among Hospital Workers in Massachusetts, 2005
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.
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[DOC File]GHTF SG5 Clinical Evaluation - IMDRF
https://info.5y1.org/fda-maude-data_1_d35ede.html
The FDA database (MAUDE) recorded 120 adverse events relating to VNS, including lead fracture, high impedance and corrosion. In the pre-MSAC response, it was acknowledged that 19 issues were detected with VNS devices between 2007 and 2018, for which corrections or removals of the product were voluntarily initiated.
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[DOC File]ACCE Article:
https://info.5y1.org/fda-maude-data_1_fac936.html
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 similar experience or if this was truly a rare event.
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[DOCX File]1491 - Final PSD
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Product specific data is searched in all databases. 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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Adverse Event Reporting Data Files | FDA
FDA MAUDE data has been investigated. Many task force members have been very busy as they are involved with different sections of this project. Some are also pursuing further education with other safety arenas on alarm issues. Expect to see notification of the white paper in the very near future. The goal will be to share this information with ...
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[DOC File]Accessible Incontinence Control Device
https://info.5y1.org/fda-maude-data_1_6a1e12.html
MAUDE US FDA’s . M. anufacturer . A. nd . U. ser Facility . D. evice . E. xperience database. MEDION Database that indexes literature on diagnostic tests. MEDLINE Published by US National Library of Medicine. Appendix B: A possible methodology for documenting the screening and selection of literature within a literature search report
maude adverse event search

[DOC File]White Paper: Health Technology Management (HTM ...
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Data from pre-specified outcomes rather than post-hoc analysis. If appropriate, provide evidence of reliability or validity, and current status of the measure (such as use in current clinical practice). ... and outcomes associated with the technology in national regulatory databases such as those maintained by the MHRA and FDA (Maude). Response.
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[DOCX File]Oxygen (Compressed Gas) Cylinder Hazard Summary
https://info.5y1.org/fda-maude-data_1_059dc1.html
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.
fda maude database adverse events

[DOCX File]Clinical Evaluation Report | Number one source for ...
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The recently released FDA, FCC, and ONC proposed rule making in response to the Food and Drug Administration Safety and Innovation Act (FDASIA) report identifies ways that Health IT and biomedical technologies are interacting in the marketplace and regulatory arena.16 Health IT professionals at all levels are finding themselves drawn ever ...
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Fda maude data