BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP TRANSOBTUR2 KIT X1

    MDR report key: 2896589 · Received November 21, 2012

    Report

    Report Number
    9615742-2012-00584
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    November 30, 2015
    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). NOTE: THIS REPORT CORRESPONDS WITH BARD'S REPORT #(B)(4) FOR A "URETEX".

    Description of Event or Problem · 1

    PROCEDURE: UROLOGICAL/GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT UNDERWENT A REPAIR PROCEDURE AND THE PT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES. 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# 1018233-2012-01765 AND 1018233-2012-01768.

    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 43 YR Female Required Intervention| O AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM| AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM