BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRASSELER USA SURGICAL CARBIDE BUR

    MDR report key: 6520590 · Received April 25, 2017

    Report

    Report Number
    2025102-2017-00001
    Event Type
    Malfunction
    Date Received
    April 25, 2017
    Date of Event
    October 21, 2016
    Report Date
    February 3, 2017
    Manufacturer
    BRASSELER U.S.A. MEDICAL, LLC
    Product Code
    GFF
    PMA / PMN Number
    K943758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURN.

    Description of Event or Problem · 1

    RECEIVED FORM 3500A (NO PEF) NOTING WHILE IN USE, THE TAPER CARBIDE FLUTED STANDARD BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300298 BRASSELER USA SURGICAL CARBIDE BUR SURGICAL CARBIDE BUR GFF BRASSELER U.S.A. MEDICAL, LLC 14-C0608 1.6 X 4.3MM TAPARED 44.5MM TOTAL LENGTH / 6 FLUTES NM5XY

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR