BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP TRANSOBTUR2 KIT X1

    MDR report key: 2250087 · Received September 9, 2011

    Report

    Report Number
    9615742-2011-00072
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    April 21, 2006
    Report Date
    August 10, 2011
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MDR REF #: 9615742-2011-00071 (AVAULTA POSTERIOR) 9615742-2011-00070 (AVAULTA ANTERIOR). NOTE: THIS REPORT CORRESPONDS WITH BARD'S REPORT (B)(4) FOR AN "URETEX."

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: UROLOGICAL / GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT UNDERWENT AN ANTERIOR AND POSTERIOR REPAIR PROCEDURE FOR TREATMENT OF PELVIC ORGAN PROLAPSE AND STRESS URINARY INCONTINENCE. THE PT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED,POSTERIOR AVAULTA MESH AS DISTAL SUBPERINEAL ARMS EXTEND FROM THE DISTAL POSTERIOR VAGINA THROUGH BUTTOCK INCISIONS THAT ARE MADE 3 CM LATERAL AND POSTERIOR TO THE ANUS - HAD POINT TENDERNESS AT 4-5 O'CLOCK POSITION IN THE INTROITUS AND APPROXIMATELY 2 CM POSTERIORLY ON THE PERINEUM OVERLYING THE OBLIQUE LINE FROM THE BUTTOCK INCISION TO THE INTROITUS AT 4-5 O'CLOCK TO SUGGEST THAT IT IS THE MESH ARM OR SLING OF THE MESH THAT TRAVELS IN THAT VICINITY CAUSING PAIN, PERHAPS THE CUTANEOUS NERVES ARE BEING COMPRESSED. UNDERWENT VAGINOPLASTY AND REVISION OF URETEX SLING AND BARD AVAULTA MESH FOR CHRONIC VAGINAL VULVAR PERINEAL PAIN, POST PLACEMENT OF POSTERIOR AVAULTA MESH AND SLING FOR SYMPTOMATIC VAGINAL RELAXATION, POINT TENDERNESS OVER LOCATION OF MESH AND DISTAL POSTERIOR AVAULTA SLING ARM (PERINEAL TRACT), MILD VAGINAL INTROITAL NARROWING (STENOSIS) UNDER GENERAL ENDOTRACHEAL ANESTHESIA. YES. FOLLOWING THE MESH REVISION SURGERY, SHE DEVELOPED DEEP VAGINAL PAIN ON PENETRATION, MIDLINE POSTERIOR MESH EROSION, POOR FASCIA AT PROXIMAL VAGINAL AREA, DYSPAREUNIA, SIGNIFICANT PELVIC RELAXATION, URODYNAMICS SHOWING LARGE BLADDER CAPACITY WITH LOW DETRUSOR PRESSURES AND POOR EMPTYING DURING THE INTERIM PERIOD (B)(6) 2006 TO (B)(6) 2012 FOR WHICH SHE HAD THE FOLLOWING ADDITIONAL SURGERIES:UNDERWENT REMOVAL OF POSTERIOR AVAULTA MESH, POSTERIOR COLPORRHAPHY UNDER GENERAL ENDOTRACHEAL ANESTHESIA FOR CHRONIC DYSPAREUNIA INVOLVING LEFT VAGINAL POSTERIOR APEX, MESH EROSION AT MID POSTERIOR VAGINA. UNDERWENT REPAIR OF ENTEROCELE, POSTERIOR REPAIR WITH BARD PELVISOFT UNDER LARYNGEAL MASK AIRWAY ANESTHESIA FOR ENTEROCELE, VAGINAL PROLAPSE, INCOMPLETE BLADDER EMPTYING. UNDERWENT REMOVAL OF VAGINAL MESH X2, REMOVAL OF VAGINAL SLING X2 UNDER GENERAL ANESTHESIA FOR VAGINAL MESH EXPOSURE, PELVIC PAIN WITH DYSPAREUNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URETEX SUPPORT PP TRANSOBTUR2 KIT X1 URETEX SUPPORT SYSTEM FTL SOFRADIM PRODUCTION SFL00436

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other| R