BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP ANTERIOR KIT X1

    MDR report key: 3111760 · Received April 17, 2013

    Report

    Report Number
    9615742-2013-00287
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    November 28, 2006
    Report Date
    April 3, 2018
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTO
    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

    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: IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, SUFFERING, DISABILITY AND IMPAIRMENT.

    Description of Event or Problem · 1

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. IN 2006 THE PATIENT HAD SYMPTOMATIC UTERINE PROLAPSE AND CYSTOCELE WITH PELVIC PRESSURE AND URINARY STRESS INCONTINENCE. DESIRES SURGICAL REPAIR. UNDER GENERAL ANESTHESIA PROCEDURE (S) PERFORMED ARE TOTAL VAGINAL HYSTERECTOMY, ANTERIOR AVAULTA COLPORRHAPHY, TENSION-FREE VAGINAL TAPE, CYSTOSCOPY, PERINEORRHAPHY. COMPLICATIONS POST AVAULTA AND URETEX PLACEMENT ARE IN 2007 THE PATIENT CONTINUED TO HAVE AN AREA OF EXPOSED MESH IN THE ANTERIOR VAGINAL WALL. THIS IS PRODUCING VAGINAL DISCHARGE AND SOME BLEEDING. TREATMENT WITH PREMARIN CREAM HAS NOT RESULTED IN CLOSURE. THE PLAN IS TO CLOSE THIS AREA SECONDARILY. ALSO UNDERWENT REVISION OF AVAULTA MESH UNDER GENERAL ANESTHESIA. COMPLICATIONS POST INTERVENTIONAL SURGERY ARE SHE HAD PROBLEMS WITH THE MESH IN THE MIDLINE BECOMING EXPOSED. SEVERAL ATTEMPTS HAVE BEEN MADE TO EXCISE THIS, BUT IT CONTINUES TO REOCCUR. FIRST MESH REVISION SURGERY: IN 2007: UNDERWENT REVISION OF AVAULTA MESH OF THE ANTERIOR VAGINAL WALL UNDER GENERAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165760 PARIETEX UGYTEX PP ANTERIOR KIT X1 AVAULTA ANTERIOR SYSTEM OTO SOFRADIM PRODUCTION ZGD00675

    Patients

    Seq Age Sex Outcome Treatment
    1 Other URETEX SUPPORT PP KIT X1: LOT #SGI00547, (B)(4)| URETEXSUP