BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP ANTERIOR KIT X1

    MDR report key: 3093913 · Received April 24, 2013

    Report

    Report Number
    9615742-2013-00308
    Event Type
    Injury
    Date Received
    April 24, 2013
    Date of Event
    October 20, 2006
    Report Date
    March 26, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    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

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED PAIN, DISABILITY AND IMPAIRMENT. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: WHAT WAS THE INDICATION FOR IMPLANTATION OF TRANSVAGINAL MESH IN THIS PATIENT? SYMPTOMATIC CYSTOURETHROCELE, RECTOCELE, STRESS URINARY INCONTINENCE, URETHRAL HYPERMOBILITY WHAT WERE THE POSTOPERATIVE COMPLICATIONS THAT THIS PATIENT DEVELOPED FOLLOWING TRANSVAGINAL PLACEMENT OF SURGICAL MESH? ON (B)(6) 2006 - UNDERWENT ANTERIOR COLPORRHAPHY, PLASTIC REPAIR OF URETHROCELE, AVAULTA POLYPROPYLENE MESH BLADDER SUSPENSION PROCEDURE, TRANS OBTURATOR PARAVAGINAL SLING PLACEMENT, SITE-SPECIFIC RECTOCELE REPAIR AND INTRAOPERATIVE CYSTOSCOPY. COMPLICATIONS POST AVAULTA IMPLANTATION: (B)(6) 2011: URINARY TRACT INFECTION, STRESS INCONTINENCE TREATED WITH LEVAQUIN. ON (B)(6) 2012: VAGINITIS, SPOTTING, AND ON EXAMINATION AREA OF EXPOSED MESH IS PRESENT ADJACENT TO DISTAL RIGHT URETHRA, BAND ON UPPER ASPECT OF MESH PALPABLE ON RIGHT, LATERAL TO DISTAL LEFT URETHRA IS MARKEDLY TENDER ARM OF MESH THAT APPEARS TO BE PRODUCING A PURULENT DISCHARGE FROM THE UPPER ASPECT OF THE MESH ON THE LEFT IS ALSO TENDER - PLANNED FOR MESH REMOVAL. ON (B)(6) 2012: PAINFUL INTERCOURSE AND PELVIC PAIN AND EXAMINATION REVEALED AREA OF MESH EXPOSURE DISTAL TO RIGHT WAS VERY TENDER AND ALSO TIGHT ARMS OF MESH WAS FELT - ROLLED EDGE ON RIGHT, TIGHT AND VERY TENDER AREA ON LEFT INTO LEVATOR ANI - PLANNED FOR MESH REMOVAL MESH REVISION SURGERY: (B)(6) 2012 - UNDERWENT CYSTOSCOPY WITH REVISION OF VAGINAL SLING TENSION FREE VAGINAL TAPE (TVT) FOR DYSPAREUNIA AND EXPOSURE OF VAGINAL MESH THROUGH VAGINAL WALL - FINDINGS - AREA OF MESH ERODED THROUGH RIGHT DISTAL ANTERIOR VAGINAL WALL. FOLLOWING MESH REVISION DID THE PATIENT PRESENT WITH SERIOUS COMPLICATIONS WHICH REQUIRED ADDITIONAL SURGERIES? YES. AS PER THE AVAILABLE MEDICAL RECORDS, SHE PRESENTED WITH COMPLICATIONS SUCH AS CONTINUED DISCHARGE WITH ODOR, PELVIC PAIN, PELVIC FLOOR MUSCLE DYSFUNCTION AND MESH EXPOSURE CAUSING DYSPAREUNIA DURING (B)(6) 2012 - (B)(6) 2013, FOR WHICH SHE UNDERWENT THE FOLLOWING ADDITIONAL MESH REVISION SURGERY ADDITIONAL MESH REVISION SURGERY: (B)(6) 2013 - UNDERWENT EXCISION/REMOVAL OF ERODED VAGINAL MESH FOREIGN BODY AND CYSTOSCOPY FOR DYSPAREUNIA AND VAGINAL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176454 PARIETEX UGYTEX PP ANTERIOR KIT X1 AVAULTA ANTERIOR SYSTEM FTL SOFRADIM PRODUCTION ZGE00368

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other