BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 4397826 · Received November 25, 2014

    Report

    Report Number
    3008788191-2014-00032
    Event Type
    Injury
    Date Received
    November 25, 2014
    Date of Event
    November 18, 2014
    Report Date
    November 25, 2014
    Manufacturer
    LAAX, INC.
    Product Code
    GDW
    PMA / PMN Number
    K111064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON NOTICED NOT APPRECIABLE BLEEDING ON THE DISTAL END OF THE TIGERPAW AFTER ITS DEPLOYMENT. THE SURGEON PUT IN SUTURES TO MAINTAIN HEMOSTASIS. TRANSFUSION WAS NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766729 TIGERPAW SYSTEM II STAPLE, IMPLANTABLE GDW LAAX, INC. TP15AJ07

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention