BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEX

    MDR report key: 861216 · Received May 31, 2007

    Report

    Report Number
    MW5002481
    Event Type
    Injury
    Date Received
    May 31, 2007
    Date of Event
    May 22, 2007
    Report Date
    May 31, 2007
    Manufacturer
    PROFEX MEDICAL PRODUCTS
    Product Code
    FMQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFEX CONDUCTIVE BODY AND LEG RESTRAINT FMQ PROFEX MEDICAL PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Disability