BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP KIT X1

    MDR report key: 3040261 · Received March 18, 2013

    Report

    Report Number
    9615742-2013-00186
    Event Type
    Injury
    Date Received
    March 18, 2013
    Date of Event
    October 20, 2008
    Report Date
    May 23, 2018
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K012949
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BRAND NAME: URETEX SUP URETHRAL SUPPORT SYSTEM. CATALOG # 485013, EXPIRATION DATE: 12/31/2012. (B)(6).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. DEVICE WAS USED FOR THERAPEUTIC TREATMENT. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Description of Event or Problem · 1

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. DEVICE WAS USED FOR THERAPEUTIC TREATMENT. THE REASON FOR MESH IMPLANTATION: MIXED URINARY INCONTINENCE. THE PROCEDURE PERFORMED: SYNTHETIC PUBOVAGINAL SLING, CYSTOSCOPY WITH SUPRAPUBIC CATHETER PLACEMENT. COMPLICATIONS POST URETEX SUP PLACEMENT: IN 2011 - URETHRAL EROSION OF VAGINAL SLING, VAULT PROLAPSE AFTER HYSTERECTOMY, STAGE II CYSTOCELE (INDIRECT INFORMATION TAKEN FROM PREOPERATIVE DIAGNOSIS OF THE OPERATIVE REPORT). COMPLICATIONS POST ADDITIONAL SURGERY: IN 2011 - BOWELS ARE FUNCTIONING SLOWLY, CONSTIPATED, MIDSTREAM SHE HAS PAIN IN THE BLADDER, DENIES INCONTINENCE - STATUS POST-SURGERY, INTERMITTENT URETHRAL PAIN - FOLLOW-UP IN 1 MONTH, GIVEN COUPON AND PRESCRIPTION FOR URINARY TRACT INFECTION (UTI). (FURTHER MEDICAL RECORDS ARE NOT AVAILABLE FOR REVIEW).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111799 URETEX SUPPORT PP KIT X1 URETEX SUPPORT FTL SOFRADIM PRODUCTION NA S1A00378

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other| R