BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 4479312 · Received December 16, 2014

    Report

    Report Number
    3008788191-2014-00039
    Event Type
    Injury
    Date Received
    December 16, 2014
    Date of Event
    July 10, 2014
    Report Date
    December 16, 2014
    Manufacturer
    LAAX INC
    Product Code
    GDW
    PMA / PMN Number
    K111064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THERE WAS BLEEDING WHERE TIGERPAW WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825494 TIGERPAW SYSTEM II STAPLE, IMPLANTABLE GDW LAAX INC TP15AJ07 0784M

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention