BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHREX

    MDR report key: 2232237 · Received July 25, 2011

    Report

    Report Number
    MW5021933
    Event Type
    Injury
    Date Received
    July 25, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 21, 2011
    Manufacturer
    ARTREX, INC.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE MULTIFIRE SCORPION INSTRUMENT WITH THE ASSOCIATED NEEDLE, THE NEEDLE GOT STUCK IN THE ROTATOR CUFF TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHREX MULTIFIRE SCORPION NEEDLE HRX ARTREX, INC. 43694A

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention