BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGERPAW SYS II

    MDR report key: 4368751 · Received November 7, 2014

    Report

    Report Number
    3008788191-2014-00009
    Event Type
    Injury
    Date Received
    November 7, 2014
    Date of Event
    August 30, 2012
    Report Date
    November 7, 2014
    Manufacturer
    LAAX INC
    Product Code
    GDW
    PMA / PMN Number
    K111064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON (B)(6) APPLIED THE TIGERPAW FASTENER (IMPLANT) ON PUMP WITH NO ISSUE. COMING OFF PUMP, THE LAA BEGAN BLEEDING. STRIPS AND SUTURE WERE USED TO CONTROL BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720772 TIGERPAW SYS II STAPLE, IMPLANTABLE GDW LAAX INC TP15AJ07 0671M

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention