BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMD UNIVERSAL SLING

    MDR report key: 1438898 · Received July 31, 2009

    Report

    Report Number
    3006142121-2009-00010
    Event Type
    Injury
    Date Received
    July 31, 2009
    Date of Event
    July 2, 2009
    Report Date
    July 31, 2009
    Manufacturer
    GENERIC MEDICAL DEVICES, INC.
    Product Code
    FTL
    PMA / PMN Number
    K083471
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: THERE WAS NO DEVICE MALFUNCTION DURING THE PROCEDURE. DEVICE FUNCTIONED ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    PHYSICIAN WAS PERFORMING A ROUTINE TRANSOBTURATOR OUTSIDE IN PROCEDURE PLACING THE GMD UNIVERSAL SLING USING AT FIRST THE GMD REUSABLE LARGE HOOK. HE THEN DROPPED THE DEVICE AND FINISHED THE PROCEDURE WITH A GMD LEFT SPIRAL TROCAR. PHYSICIAN WAS PLACING SUTURE IN THE VAGINAL INCISION (FINISHING UP THE PROCEDURE) AND DISCOVERED THAT THE SLING WAS PLACED THROUGH THE VAGINAL WALL. PHYSICIAN THEN REMOVED LEFT SIDE AND RETHREADED THE MESH IN THE APPROPRIATE LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GMD UNIVERSAL SLING FTL -SURGICAL MESH FTL GENERIC MEDICAL DEVICES, INC. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other