BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARIETEX UGYTEX PP 15X10CM X1

    MDR report key: 2901031 · Received December 6, 2012

    Report

    Report Number
    9615742-2012-00641
    Event Type
    Death
    Date Received
    December 6, 2012
    Date of Event
    April 23, 2010
    Report Date
    November 9, 2012
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K033376
    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).

    Additional Manufacturer Narrative · 1

    (B)(4). ADD'L DATA FROM IMPORTER REPORT: DATE OF REPORT - (B)(4) 2012; DEVICE INFO - PELVITEX POLYPROPYLENE MESH; CATALOG #486015; (B)(6).

    Description of Event or Problem · 1

    PROCEDURE: UROLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. ADD'L DATA FROM IMPORTER REPORT: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED,DIFFICULTY WITH BOWEL FUNCTION - WOUND DEHISCENCE - ODOFORM DRESSING GIVEN.ABDOMINAL PAIN AND SEVERE CRAMPING, BOWEL OBSTRUCTION SINCE SURGERY - SCHEDULED FOR SURGERY TO RELIEVE OBSTRUCTION. REASON FOR SURGERY: PERSISTENT PARTIAL SMALL BOWEL OBSTRUCTION WITH ABDOMINAL PAIN - UNDERWENT DIAGNOSTIC LAPAROSCOPY, LYSIS OF ADHESIONS, CONVERSION TO OPEN LAPAROTOMY, SEGMENTAL SIGMOID COLECTOMY WITH PRIMARY COLOCOLOSTOMY AT CLOSURE, INJURY TO THE BLADDER TIMES TWO, REPAIRED TIMES TWO, RESECTION OF DISTAL ILEUM AND CECUM WITH PRIMARY ILEOCOLOSTOMY, PLACEMENT OF CLOSED SUCTION DRAINAGE OF THE PELVIS. INTERSTITIAL CYSTITIS, URGENCY, DYSURIA, CHRONIC PELVIC PAIN, INCONTINENCE, BLADDER INFECTION, LOWER ABDOMINAL BLOATING, PAIN IN RECTUM, CYSTOCELE WITH ANTERIOR VAULT DESCENT - TREATED WITH MEDICATIONS AND BLADDER INSTILLATIONS.INTERSTITIAL CYSTITIS, HOT FLASHES, DYSPAREUNIA, CHRONIC PELVIC PAIN, URGENCY, FREQUENCY, INCONTINENCE, URINARY TRACT INFECTIONS, DYSURIA, VULVAR LESION, VULVAR LUMP, PERINEAL NODULE. ON EXAMINATION SUTURE FIBROMA AT POSTERIOR FOURCHETTE WAS NOTED. SCHEDULED FOR MESH REVISION. REASON FOR SURGERY - PELVIC PAIN, TENDER PERINEAL NODULE/MESH EROSION FROM PREVIOUS SURGERY AND TENDER URETHROCELE - UNDERWENT EXCISION OF PERINEAL CYST/MESH EROSION, SLING REVISION AND CYSTOSCOPY. YES. FOLLOWING MESH REVISION SURGERY SHE DEVELOPED COMPLICATIONS SUCH AS PELVIC PAIN, PERINEAL PAIN, STITCH GRANULOMA URGENCY, FREQUENCY, DYSURIA, INTERSTITIAL CYSTITIS, DYSPAREUNIA, CHRONIC PELVIC PAIN, VAGINAL DISCOMFORT, VAGINAL IRRITATION, VULVOVAGINAL CANDIDIASIS DURING (B)(6) 2011- (B)(6) 2012, AND UNDERWENT TWO IN-OFFICE PERINEAL SUTURE REMOVALS BUT DID NOT UNDERGO ANY ADDITIONAL SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARIETEX UGYTEX PP 15X10CM X1 PELVITEX MESH FTL SOFRADIM PRODUCTION NA PJE00408

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death| O| R