BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 4391877 · Received November 18, 2014

    Report

    Report Number
    3008788191-2014-00020
    Event Type
    Injury
    Date Received
    November 18, 2014
    Date of Event
    November 20, 2013
    Report Date
    November 17, 2014
    Manufacturer
    LAAX INC
    Product Code
    GDW
    PMA / PMN Number
    K111064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TORE THE LEFT ATRIAL APPENDAGE. THE APPENDAGE WAS FRIABLE PER DR (B)(6). THE TEAR WAS REPAIRED BY 2 FELT STRIPS WITH INTERRUPTED PROLENE SUTURES. BLEEDING WAS CONTROLLED AFTER REPAIR. THE AMOUNT OF BLOOD LOSS IS UNK. A BLOOD TRANSFUSION WAS NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747261 TIGERPAW SYSTEM II STAPLE, IMPLANTABLE GDW LAAX INC TP15AJ07 0972M

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention