BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP ANTERIOR KIT X1

    MDR report key: 3202314 · Received June 21, 2013

    Report

    Report Number
    9615742-2013-00591
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    April 25, 2006
    Report Date
    June 5, 2018
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTP
    PMA / PMN Number
    K051503
    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

    EXEMPTION NUMBER: (B)(4). (B)(4). UF/IMPORTER REPORT NUMBER: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. PELVISOFT ACELLULAR COLLAGEN BIOMESH WAS REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE.

    Description of Event or Problem · 1

    THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. IT WAS REPORTED THAT AFTER A PROCEDURE WHERE THIS DEVICE WAS IMPLANTED, THE PATIENT EXPERIENCED POSTMENOPAUSAL SYMPTOMS OF HOT FLASHES, DEPRESSION, ANXIETY, MOOD SWINGS, NIGHT SWEATS, AND DIFFICULTY SLEEPING, CYSTORECTOCELE, RECTOCELE, RECURRENT PROLAPSE SYMPTOMS, RECURRENT RELAXATION, ENTEROCELE, AND WEAK RECTOVAGINAL TISSUE. THE PATIENT REQUIRED SURGICAL AND NON-SURGICAL INTERVENTIONS SUCH AS RECTOCELE REPAIR AND PLACEMENT OF PORCINE GRAFT MATERIAL AND POSTERIOR WALL, AND CYSTOSCOPY, HORMONE REPLACEMENT THERAPY, AND USE OF A PESSARY. THE INDICATION FOR IMPLANTATION OF TRANSVAGINAL MESH IN THIS PATIENT IS UTEROVAGINAL PROLAPSE, ENTEROCELE, CYSTOCELE, STRESS INCONTINENCE. THE POSTOPERATIVE COMPLICATIONS THAT THIS PATIENT DEVELOPED FOLLOWING TRANSVAGINAL PLACEMENT OF SURGICAL MESH IN 2006: PATIENT UNDERWENT TOTAL VAGINAL HYSTERECTOMY, INTRAPERITONEAL COLPOPEXY, CYSTOCELE REPAIR, MESH PLACEMENT ALONG THE ANTERIOR VAGINAL WALL (AVAULTA), SUBURETHRAL SLING (GYNECARE TVT), AND CYSTOSCOPY. COMPLICATIONS POST-AVAULTA IMPLANTATION: 2006 RECTOCELE REPAIR WITH GRAFT PLACEMENT. DR. (B)(6) IS CONSIDERING PLACING A PORCINE DERMIS AND ATTACHING TO THE SACRAL SPINOUS LIGAMENTS USING THE CAPIO DEVICE. ADDITIONAL IMPLANT SURGERY: 2006: UNDERWENT RECTOCELE REPAIR AND PLACEMENT OF PORCINE GRAFT MATERIAL AND POSTERIOR WALL AND CYSTOSCOPY. COMPLICATIONS POST-ADDITIONAL IMPLANT SURGERY: 2006: SHE COMPLAINED OF BRIGHT RED VAGINAL BLEEDING. SHE HAS PAIN AT HER TAIL BONE. 2007: SHE REQUESTS EVALUATION FOR QUESTIONABLE PROLAPSE RECURRENCE. SHE STATES, ¿FEELS SOMETHING DIFFERENT SINCE MONDAY¿. A DVISED TO CONTINUE WITH COLACE. SHE DEFINITELY SHOULD RETURN TO ANY ACTIVITIES THAT SHE WANTS TO RETURN TO INCLUDING EXERCISE AND WOULD LIKE TO SEE HER BACK IN (B)(6) 2008: SHE WAS STRAINING WITH OCCASIONAL CONSTIPATION AND ADVISED TO USE SOFTENER DAILY. SHE WAS FEELING BULGE WHEN ON FEET FOR EXTENDED PERIOD OF TIME. 2008: SHE STATES SHE IS AWARE OF SOMETHING HAVING FALLEN INTO THE VAGINA. SHE HAS MINIMAL LOWER URINARY TRACT SYMPTOMS, NAMELY THAT OF OCCASIONAL URGENCY WITH A FULL BLADDER. RECOMMENDED INTERMITTENT USE OF HER VAGINAL SUPPORT PESSARY FOR EVEN SIMPLY A TAMPON DURING MOMENTS OF INCREASED VIGOROUS ACTIVITY TO DECREASE THE BOTHER FACTOR OF HER VAGINAL FULLNESS. IF ALL OF THESE MEASURES DO NOT PROVIDE SUFFICIENT IMPROVEMENT OR RELIEF, THEN, BY ALL MEANS WE CAN REVISIT A SURGICAL APPROACH. SHE WANTS TO TRY PATCH FOR 3 MONTHS. PRESCRIBED CLIMARA 0.025 GM FOR A WEEK. RECOMMENDED TO SEE DR. (B)(6). 2009: RECURRENT CYSTOCELE, MILD ATROPHY, WEAKENED PFM. PLAN ¿ RECOMMENDED KEGEL, TOPICAL E2. 2011: SHE PRESENTED FOR PROLAPSE ISSUES. PRESCRIBED VAGIFEM 10 MCG, CLIMARA 0.025%. 2012: SHE WISHES TO CONTINUE PATCH ¿ ¿FORGETS¿ VAGIFEM ¿ WILL TRY ESTRING. ON (B)(6) 2012 SHE PHONED AND REPORTED ¿FALLS OUT¿. PELVIC ULTRASOUND FOR POSTMENOPAUSAL SYMPTOMS WAS PERFORMED WHICH SHOWED ATROPHIC OVARIES. PRESCRIBED ESTRING 2 MG INSERT VAGINALLY, CLIMARA 0.025%. 2013: SHE DECLINES CLIMARA. WILL CONTINUE ESTRING, HORMONAL SUPPLEMENT/TESTOSTERONE CREAM FROM DR. (B)(6). RETURN TO CLINIC ONE YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282797 PARIETEX UGYTEX PP ANTERIOR KIT X1 AVAULTA ANTERIOR SYSTEM OTP SOFRADIM PRODUCTION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other