BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMD UNIVERSAL SLING

    MDR report key: 1417003 · Received July 20, 2009

    Report

    Report Number
    3006142121-2009-00006
    Event Type
    Injury
    Date Received
    July 20, 2009
    Date of Event
    June 23, 2009
    Report Date
    June 23, 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 RETROPUBIC INSIDE-OUT PROCEDURE PLACING THE GMD UNIVERSAL SLING USING THE GMD SPIRAL SHAPED TROCAR. PHYSICIAN NOTICED THAT BLADDER WAS PERFORATED AND REMOVED THE SLING-SLEEVE TROCAR, RE-ROUTING TROCAR FROM OUTSIDE-IN APPROACH. A SECOND CYSTOSCOPY CONFIRMED SLING HAD BEEN ANATOMICALLY IN PREFERRED POSITION.

    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