BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 4391918 · Received November 20, 2014

    Report

    Report Number
    3008788191-2014-00025
    Event Type
    Injury
    Date Received
    November 20, 2014
    Date of Event
    February 7, 2014
    Report Date
    November 20, 2014
    Manufacturer
    LAAX INC
    Product Code
    GDW
    PMA / PMN Number
    K111064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHEN THE TIGERPAW WAS APPLIED TO THE APPENDAGE, IT CUT THE ATRIUM ON THE HEART SIDE. THE CUT HAD TO BE SOWN TO STOP THE BLEEDING (THE SEVERITY OF BLEEDING IS UNK). NO REPORTED PT AFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755409 TIGERPAW SYSTEM II STAPLE, IMPLANTABLE GDW LAAX INC TP15AJ07 0991M

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention