BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 4391892 · Received November 19, 2014

    Report

    Report Number
    3008788191-2014-00021
    Event Type
    Injury
    Date Received
    November 19, 2014
    Date of Event
    November 27, 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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LEFT ATRIAL APPENDAGE WAS TORN. PLEDGETED SUTURE WAS USED TO CONTROL BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751841 TIGERPAW SYSTEM II STAPLE, IMPLANTABLE GDW LAAX INC TP15AJ07 0972M

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention