BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 4397827 · Received November 26, 2014

    Report

    Report Number
    3008788191-2014-00033
    Event Type
    Injury
    Date Received
    November 26, 2014
    Report Date
    November 26, 2014
    Manufacturer
    LAAX, INC
    Product Code
    GDW
    PMA / PMN Number
    K111064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TEAR (THE BASE OF THE APPENDAGE). SUTURES WERE USED TO REPAIR THE TORN AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769814 TIGERPAW SYSTEM II STAPLE, IMPLANTABLE GDW LAAX, INC TP15AJ0X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention