BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMD UNIVERSAL SLING

    MDR report key: 1533027 · Received November 5, 2009

    Report

    Report Number
    3006142121-2009-00014
    Event Type
    Malfunction
    Date Received
    November 5, 2009
    Date of Event
    October 14, 2009
    Report Date
    November 4, 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: NO DEVICE MALFUNCTION DURING PROCEDURE. DEVICE FUNCTIONED ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    DR PERFORMED 3 SURGERIES ON PTS USING THE GMD SLING ONE RIGHT AFTER ANOTHER USING A TO-OI APPROACH. BLUE SLEEVES WERE CUT; A CLAMP WAS CAREFULLY PLACED ONTO THE SHEATH. DR ATTEMPTED TO CLEAR SHEATH BY USING A PULLING MOTION; A LARGE AMOUNT OF PRESSURE WAS EXERTED, AND DESPITE THE FACT THAT THE SHEATH WAS NOT REMOVING FROM THE MESH. DR DOUBLE CHECKED THAT BOTH THE MESH AND THE SHEATH WERE NOT CLAMPED TOGETHER, IT WAS CONFIRMED THAT WAS NOT THE CASE. SIGNIFICANT PRESSURE WAS ONCE AGAIN USED BY THE DR AND EVENTUALLY THE CLEAR SHEATH DID REMOVE FROM THE MESH AND IMPLANT WAS SUCCESSFUL IN ALL 3 CASES. DURING THE PT'S POST OP CHECKUP, IT WAS DISCOVERED THAT 2 OF THE 3 PTS IMPLANTED (WITH DIFFICULTY REMOVING THE SHEATH FROM THE MESH) HAD EXPERIENCED URINARY RETENTION. THE PHYSICIAN DETERMINED AT THIS POINT SHE WOULD FOLLOW THEM FOR NOW AND SEE IF THE PROBLEM RESOLVED ITSELF. ON THE 2ND POST OP VISIT, BOTH PTS WERE STILL IN RETENTION AND THE PHYSICIAN ELECTED TO ADJUST THE IMPLANTED SLINGS ON BOTH PTS. WHEN THE 2 PTS RETURNED FOR A 3RD POST OP VISIT AND THEIR CONDITION HAD STILL NOT IMPROVED (NOW 9 DAYS POST OP), THE PHYSICIAN ELECTED TO REMOVE BOTH PTS' GMD SLINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GMD UNIVERSAL SLING FTL-SURGICAL MESH FTL GENERIC MEDICAL DEVICES, INC. 1015-06 21616

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other