BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS

    MDR report key: 1671986 · Received May 3, 2010

    Report

    Report Number
    2125050-2010-00006
    Event Type
    Injury
    Date Received
    May 3, 2010
    Date of Event
    April 1, 2009
    Report Date
    April 5, 2010
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    FTL
    PMA / PMN Number
    K050148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE LOT NUMBER NOR THE DEVICE WERE AVAILABLE, SO NO EVALUATION COULD BE PERFORMED. VAGINAL EROSION, EXTRUSION, DEHISCENCE AND INFECTION ARE KNOWN COMPLICATIONS ASSOCIATED WITH THE USE OF BOTH SYNTHETIC AND AUTOLOGOUS/DONOR TISSUE PUBO-VAGINAL SLINGS FOR TREATMENT OF URINARY INCONTINENCE. SURGICAL TECHNIQUE VARIABLES AND A HISTORY OF PREVIOUS OR CONCURRENT URO-GYNECOLOGY SURGICAL PROCEDURES CAN AFFECT THE RATE OF THIS OCCURRENCE. IN ADDITION, PRE-EXISTING CO-MORBIDITIES THAT AFFECT HEALING SUCH AS OBESITY, HYPERTENSION, IMMUNOSUPPRESSION, DIABETES, RECURRENT VAGINAL OR URINARY TRACT INFECTIONS, AND POST-MENOPAUSAL VAGINAL MUCOSAL CHANGES CAN CONTRIBUTE TO AN INCREASED INCIDENCE OF THESE EVENTS. DEVICE NOT RETURNED

    Description of Event or Problem · 1

    (B) (4). AS REPORTED TO COLOPLAST, A PATIENT EXPERIENCED EROSION OF THE DEVICE. ONE MONTH AFTER IMPLANT, THE PATIENT BEGAN TO EXPERIENCE INTENSE NEURALGIA IN GENITAL AREA. IT WAS DETERMINED THAT THE MESH HAD GONE THROUGH THE OBTURATOR NERVE AND WAS CAUSING THE NEURALGIA. IN ADDITION, THE SUI RETURNED, SO THE SLING ALSO FAILED IN THE INITIAL FUNCTION. THE MESH WAS REMOVED, THE DOCTOR DID A RESECTION OF THE PELVIC FLOOR, AND THE NEURALGIA HAS SIGNIFICANTLY SUBSIDED. DATES OF USE: 2008-2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARIS TRANS-OBTURATOR TAPE FTL COLOPLAST MANUFACTURING US, LLC 5195501000 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention