BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROWARD

    MDR report key: 1993089 · Received February 8, 2011

    Report

    Report Number
    MW5019400
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 8, 2011
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE OPERATION, A TEAR WAS VISUALIZED IN THE SUPER TURBOVAC ATHROWARD INSULATION. A PIECE OF PLASTIC COATING WAS SEEN IN THE JOINT & REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROWARD SUPER TURBO-VAC 90 WARD GEI E233400-A

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR