BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 4391916 · Received November 20, 2014

    Report

    Report Number
    3008788191-2014-00024
    Event Type
    Injury
    Date Received
    November 20, 2014
    Date of Event
    December 12, 2013
    Report Date
    November 20, 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

    ONE SUTURE WAS USED AFTER TIGERPAW DEPLOYMENT TO CONTROL BLEEDING AT THE ELBOW OF DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755408 TIGERPAW SYSTEM II STAPLE, IMPLANTABLE GDW LAAX INC TP15AJ07

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention