BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP TRANSOBTUR2 KIT X1

    MDR report key: 2896556 · Received December 13, 2012

    Report

    Report Number
    9615742-2012-00667
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    August 5, 2010
    Report Date
    May 24, 2018
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K041176
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION FROM IMPORTER REPORT: DATE OF THIS REPORT: (B)(6) 2012, BRAND NAME: URETEX TO2 URETHRAL SUPPORT SYSTEM, CATALOG #485054, (B)(6). (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE PT: THE PT'S ATTORNEY HAS ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM- POSTERIOR WAS REPORTED TO BE USED/IMPLANTED DURING THE SAME PROCEDURE. ADDITIONAL INFORMATION FROM IMPORTER REPORT: THE PT'S ATTORNEY HAS ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2012-02048.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URETEX SUPPORT PP TRANSOBTUR2 KIT X1 URETEX SUPPORT FTL SOFRADIM PRODUCTION NA SGJ00155

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Other AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM: POSTERIOR| AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM: POSTERIOR