BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 4951532 · Received July 28, 2015

    Report

    Report Number
    3008788191-2015-00017
    Event Type
    Injury
    Date Received
    July 28, 2015
    Report Date
    February 29, 2012
    Manufacturer
    LAAX INC
    Product Code
    GDW
    PMA / PMN Number
    K111064
    Removal / Correction Number
    Z-1461-2015, Z-1462-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HEALTH HAZARD EVALUATION (HHE) WAS COMPLETED.

    Description of Event or Problem · 1

    BARBS IN THE MIDDLE OF THE FASTENER FAILED TO BE CLOSED. THERE WAS BLEEDING BUT NOT A MEASURABLE AMOUNT. THE SURGEON SUTURED AROUND THE FASTENER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490686 TIGERPAW SYSTEM II STAPLE, IMPLANTABLE GDW LAAX INC TP15AJ07

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention