BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP KIT X1

    MDR report key: 3041995 · Received April 3, 2013

    Report

    Report Number
    9615742-2013-00227
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    May 26, 2005
    Report Date
    May 7, 2018
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K012949
    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

    MEDTRONIC COMPLAINT REPORT: (B)(4). ADDITIONAL INFORMATION: (B)(4): DYSPAREUNIA, REVISION. 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.

    Description of Event or Problem · 1

    PROCEDURE: UNDERWENT ANTERIOR COLPORRHAPHY WITH CYSTOCELE REPAIR, SLING URETHROPEXY (URETEX) WITH CYSTOSCOPY, POSTERIOR COLPORRHAPHY WITH RECTOCELE REPAIR, VAGINAL ENTEROCELE REPAIR, PERINEOPLASTY POSTOPERATIVE COMPLICATIONS: PAIN, INFECTION, RECURRENCE, BLEEDING, DYSPAREUNIA MESH REVISION SURGERY: (B)(6) 2012: UNDERWENT EXCISION OF SUBURETHRAL SLING, CYSTOCELE REPAIR, CYSTOSCOPY UNDER GENERAL ANESTHESIA FOR PREVIOUS SLING, DYSPAREUNIA, PELVIC PAIN, IRRITATIVE VOIDING SYMPTOMS AND CYSTOCELE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136388 URETEX SUPPORT PP KIT X1 URETEX SUPPORT FTL SOFRADIM PRODUCTION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other