BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP TRANSOBTUR2 KIT X1

    MDR report key: 2900332 · Received December 21, 2012

    Report

    Report Number
    9615742-2012-00680
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    February 6, 2007
    Report Date
    November 30, 2012
    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
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADD'L DATA FROM IMPORTER REPORT: (B)(4) 2012; URETEX TO2 URETHRAL SUPPORT SYSTEM; CATALOG #: 485054; (B)(6).

    Description of Event or Problem · 1

    PROCEDURE: UROLOGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. PER ADD'L INFO RECEIVED, THE PT HAS EXPERIENCED AN APICAL PROLAPSE WITH "A GOOD SIZED" ENTEROCELE BETWEEN PREVIOUSLY GRAFTS. 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. PER ADD'L INFO RECEIVED, THE PT HAS EXPERIENCED AN APICAL PROLAPSE WITH "A GOOD SIZED" ENTEROCELE BETWEEN PREVIOUSLY PLACED GRAFTS. ASSOCIATED MDRS: 1018233-2012-02087, 1018233-2012-02089 AND 1018233-2012-02088.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URETEX SUPPORT PP TRANSOBTUR2 KIT X1 URETEX SUPPORT FTL SOFRADIM PRODUCTION NA SGJ00260

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other| R BARD AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM| BARD AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM