BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADE BRASSELER

    MDR report key: 10332040 · Received July 27, 2020

    Report

    Report Number
    MW5095741
    Event Type
    Malfunction
    Date Received
    July 27, 2020
    Date of Event
    July 21, 2020
    Report Date
    July 23, 2020
    Manufacturer
    BRASSELER U.S.A. MEDICAL, LLC
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SAW BLADE BROKE WHILE IN USE IN DRILL. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788787 BLADE BRASSELER BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA BRASSELER U.S.A. MEDICAL, LLC KM3 225

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR