BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 4391883 · Received November 19, 2014

    Report

    Report Number
    3008788191-2014-00023
    Event Type
    Injury
    Date Received
    November 19, 2014
    Date of Event
    December 23, 2013
    Report Date
    November 19, 2014
    Manufacturer
    LAAX INC
    Product Code
    GDW
    PMA / PMN Number
    K111064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BLEEDING (TEAR) AT THE BASE (RIGHT BELOW THE LOWER POINT) OF THE DEVICE JAW AFTER THE DEVICE WAS DEPLOYED. REPAIR WAS DONE WITH A PLEDGETED PROLENE STITCH. PT DID FINE AFTER AND HAD A NORMAL POSTOPERATIVE COURSE. THERE WAS NO TRANSFUSION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751999 TIGERPAW SYSTEM II STAPLE, IMPLANTABLE GDW LAAX INC TP15AJ07 0759M

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention