BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGREPAW SYSTEM II

    MDR report key: 4397828 · Received November 26, 2014

    Report

    Report Number
    3008788191-2014-00034
    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 Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THERE WAS BLEEDING ON THE LEFT ATRIAL APPENDAGE BASED ON THE TEAR THAT WAS SUTURED. THE PT DID NOT REQUIRE A BLOOD TRANSFUSION, AND THE AMOUNT OF BLOOD LOSS WAS NOT NOTED. THE PT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770229 TIGREPAW SYSTEM II STAPLE, IMPLANTABLE GDW LAAX, INC TP15AJ07

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention