BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX MESH PRODUCT

    MDR report key: 3952010 · Received July 15, 2014

    Report

    Report Number
    9615742-2014-00226
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    September 26, 2003
    Report Date
    June 30, 2014
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4), (IMPORTER).

    Description of Event or Problem · 1

    PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT ALLEGED INJURY.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED,COMPLAINS OF SOME PAIN ON HER LEFT SIDE, CRAMPING, CONSTIPATION, THICK WHITE DISCHARGE, CERVICAL MOTION, UTERINE AND ADNEXAL TENDERNESS - PELVIC INFLAMMATORY DISEASE (PID), SHE IS CONTINENT, URINARY STREAM IMPROVED. SEVERE DYSURIA, STRESS INCONTINENCE AND VAGINAL PAIN -SUSPECT WHETHER THE SLING HAS ERODED. PALPATION OF THE SLING DEMONSTRATES EXQUISITE PAIN IN THE ANTERIOR VAGINAL WALL RIGHT AT THE BLADDER NECK. MESH REVISION SURGERY: (B)(6) 2008 -UNDERWENT REMOVAL OF PUBOVAGINAL SLING FOR ERODED PUBOVAGINAL SLING. FOLLOWING MESH REVISION DID THE PATIENT PRESENT WITH SERIOUS COMPLICATIONS WHICH REQUIRED ADDITIONAL SURGERIES?YES. AS PER THE AVAILABLE MEDICAL RECORDS PATIENT DEVELOPED RECURRENT STRESS URINARY INCONTINENCE, GRAFT EXTRUSION AND DYSPAREUNIA FOR WHICH SHE UNDERWENT AN ADDITIONAL MESH REVISION SURGERY:SECOND MESH REVISION SURGERY: (B)(6) 2013 -UNDERWENT EXAMINATION UNDER ANESTHESIA, VAGINAL GRAFT REVISION/URETHROLYSIS AND CYSTOSCOPY FOR RECURRENT STRESS URINARY INCONTINENCE, GRAFT EXTRUSION AND DYSPAREUNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413097 URETEX MESH PRODUCT URETEX MESH OTN SOFRADIM PRODUCTION

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other