BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP KIT X1

    MDR report key: 2901096 · Received November 7, 2012

    Report

    Report Number
    9615742-2012-00559
    Event Type
    Injury
    Date Received
    November 7, 2012
    Report Date
    October 10, 2012
    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

    (B)(4). NOTE: THIS REPORT CORRESPONDS WITH BARD'S REPORT #410785 FOR A "URETEX." ADDITIONAL INFORMATION FROM THE IMPORTER REPORT: (B)(6) 2012, URETEX SUP URETHRAL SUPPORT SYSTEM, CATALOG # 485013, (B)(6). ATTORNEY.

    Description of Event or Problem · 1

    PROCEDURE: UROLOGICAL/GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT UNDERWENT A REPAIR PROCEDURE AND THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PATIENT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES. THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, FOLLOWING MESH IMPLANTATION, PATIENT PRESENTED TO ER ON (B)(6) 2004 WITH ACUTE ABDOMINAL PAIN AND FEVER OVER THE PAST 3 DAYS. EXAMINATION OF ABDOMEN REVEALS TENDERNESS AND REBOUND IN ALL FOUR QUADRANTS AND POSITIVE ROVSING SIGN. URINALYSIS SHOWED PYURIA AND CT OF THE ABDOMEN SHOWS FLUID AND INFLAMMATION IN THE AREA OF THE PELVIS AND SIGMOID COLON WITH A PARALYTIC ILEUS. DIAGNOSED POST VAGINAL HYSTERECTOMY WITH SIGNS AND SYMPTOMS OF PERITONITIS AND POSSIBLE POST SURGICAL WOUND INFECTION VERSUS PERFORATED COLON. PLANNED SIGMOIDOSCOPY AND DEFINITE TREATMENT. UNDERWENT DIAGNOSTIC LAPAROSCOPY WITH LAPAROSCOPIC LEFT OOPHORECTOMY FOR ACUTE ABDOMEN PAIN FINDINGS LEFT OVARIAN ABSCESS. PELVIC PAIN, CONSTANT PRESSURE IN LOWER ABDOMEN, UNABLE TO HOLD URINE UTI AND URINARY FREQUENCY. CT OF ABDOMEN AND PELVIS ON (B)(6) 2006 REVEALED SMOOTH CYSTS OF BOTH KIDNEYS WHICH APPEAR UNCOMPLICATED. BACTERIAL VAGINOSIS, PRURITUS. RECOMMENDED METROGEL, FLAGYL, PROCTOCORT SUPPOSITORY. ULTRASOUND OF PELVIS ((B)(6) 2009) PERFORMED FOR RECENT PELVIC INFECTION REVEALED UNREMARKABLE APPEARANCE OF THE LEFT OVARY WITH NO FLUID DEMONSTRATED. ATROPHIC VULVOVAGINITIS, CANDIDAL VULVOVAGINITIS ((B)(6) 2011), CHRONIC SPASM OF PELVIC MUSCLES PFPT. SUSPECTED IF A VAGINAL MESH, OR HER SLING COULD CAUSE THESE CONSTANT INFECTIONS ((B)(6) 2012). PRESCRIBED ESTRACE, DIFLUCAN. MESH CAN BE PALPATED UNDERNEATH URETHRA, CAUSES MUCH PAIN, MUCOSA OVER MESH SEEMS THIN ATROPHIC VULVOVAGINITIS, LICHEN SCLEROSUS ET ATROPHICUS OF THE VULVA AND EROSION OF IMPLANTED VAGINAL MESH AND PROSTHETIC MATERIALS, PAIN DUE TO VAGINAL MESH PRESCRIBED BETAMETHASONE, CONTINUED ON PREMARIN. RECOMMENDED REMOVAL OF VAGINAL MESH. UNDERWENT REMOVAL OF PELVIC MESH PRODUCTS FOR PELVIC AND VAGINAL PAIN (PER PFS). (PER PFS, IT IS MENTIONED THAT PATIENT UNDERWENT REMOVAL OF MESH PRODUCTS ON (B)(6) 2012, BUT ORIGINAL OPERATIVE REPORT FOR MESH REVISION SURGERY IS NOT AVAILABLE, HOWEVER PER VISIT DATED (B)(6) 2012, IT IS MENTIONED THAT MESH HAS BEEN REMOVED).YES. FOLLOWING MESH REVISION SURGERY, SHE DEVELOPED COMPLICATIONS BUT DID NOT UNDERGO ANY ADDITIONAL SURGERY. PER LAST AVAILABLE RECORDS DATED (B)(6) 2012, PATIENT HAS TROUBLE HOLDING URINE, DIAGNOSED WITH URINARY INCONTINENCE, ADVERSE EFFECT OF MESH AND DISCUSSED WITH SURGEON REGARDING INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URETEX SUPPORT PP KIT X1 URETEX SUPPORT FTL SOFRADIM PRODUCTION NA C24015SUP

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other| R