BEUDAMED
    FDA Adverse Event Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 5044547 · Received August 28, 2015

    Report

    Report Number
    3008788191-2015-00129
    Date Received
    August 28, 2015
    Date of Event
    February 13, 2015
    Report Date
    March 4, 2015
    Manufacturer
    LAAX INC
    Product Code
    GDW
    PMA / PMN Number
    K111064
    Removal / Correction Number
    Z-1461-2015; Z-1462-2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    HEALTH HAZARD EVALUATION (HHE) WAS COMPLETED.

    Description of Event or Problem · 1

    TISSUES WERE TORN AFTER THE TIGERPAW SYSTEM II DEVICE WAS USED (APPENDAGE WAS OCCLUDED). SUTURES WERE USED TO STOP SMALL BLEEDING. THERE WERE NO PATIENT NEGATIVE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573467 TIGERPAW SYSTEM II STAPLE, IMPLANTABLE GDW LAAX INC TP15AJ09 1201M

    Patients

    Seq Age Sex Outcome Treatment
    1