BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 4988450 · Received August 5, 2015

    Report

    Report Number
    3008788191-2015-00087
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 9, 2014
    Report Date
    August 1, 2014
    Manufacturer
    LAAX, INC.
    Product Code
    GDW
    PMA / PMN Number
    K111064
    Removal / Correction Number
    Z-1461-2015, Z-1462-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    HEALTH HAZARD EVALUATION (HHE) WAS COMPLETED.

    Description of Event or Problem · 1

    THE TIGERPAW SYSTEM II DIDN'T DEPLOY CORRECTLY. THE SECOND TIGERPAW SYSTEM II DEVICE WAS SUCCESSFULLY USED TO COMPLETE OCCLUSION. THERE WAS NO BLEEDING BASED ON THIS EVENT. THERE WERE NO PATIENT NEGATIVE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516007 TIGERPAW SYSTEM II STAPLE, IMPLANTABLE GDW LAAX, INC. TP15AJ09 1121M

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR