BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP KIT X1

    MDR report key: 2930526 · Received January 16, 2013

    Report

    Report Number
    9615742-2013-00025
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    June 19, 2006
    Report Date
    April 11, 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).

    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 PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD¿L INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Description of Event or Problem · 1

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE INDICATION FOR IMPLANTATION OF TRANSVAGINAL MESH IN THIS PATIENT IS STRESS INCONTINENCE. THE POSTOPERATIVE COMPLICATIONS THAT THIS PATIENT DEVELOPED FOLLOWING TRANSVAGINAL PLACEMENT OF SURGICAL MESH IS IN 2006 ¿ UNDERWENT ANTERIOR REPAIR AND PUBOVAGINAL (URETEX) SLING PLACEMENT UNDER GENERAL ANESTHESIA. COMPLICATIONS POST URETEX PLACEMENT IN 2010: HAD BURNING WITH URINATION FOR 2 WEEKS. ASSESSED WITH URINARY TRACT INFECTION (UTI). PRESCRIBED DITROPAN, OXYBUTYNIN 5 MG, PYRIDIUM AND VICODIN. HAD RECURRENT BLADDER INFECTION. PRESCRIBED CIPROFLOXACIN, VICODIN 500 MG. IN 2013 HAD LOW BACK PAIN AND UTI. HAD FREQUENCY WITH LEAKAGE OF URINE AND INCONTINENCE. ON CIPROFLOXACIN 500 MG. PRESCRIBED LEVAQUIN 750 MG, OXYBUTYNIN 5 MG. REFER UROLOGIST FOR INCONTINENCE. URINALYSIS IN 2 WEEKS. IN 2013 THE PATIENT HAD A UTI. BLADDER BIOPSY DONE. ORDERED FOR URINALYSIS IN 2 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24158 URETEX SUPPORT PP KIT X1 URETEX SUPPORT FTL SOFRADIM PRODUCTION NA D24289SUP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other