BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMD UNIVERSAL SLING

    MDR report key: 1422431 · Received July 27, 2009

    Report

    Report Number
    3006142121-2009-00008
    Event Type
    Injury
    Date Received
    July 27, 2009
    Date of Event
    July 1, 2009
    Report Date
    July 1, 2009
    Manufacturer
    GENERIC MEDICAL DEVICE, 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

    EVALUATION CODES: OTHER - THERE WAS NO DEVICE MALFUNCTION DURING THE PROCEDURE. DEVICE FUNCTIONED ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    PHYSICIAN WAS PERFORMED A RETROPUBIC OUTSIDE-IN PROCEDURE FOR URINARY INCONTINENCE USING THE GMD UNIVERSAL SLING IN 2009 WITHOUT INCIDENT. A WEEK LATER, PT EXPERIENCED RETENTION. NO FURTHER INFORMATION ON PT IS KNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other