BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP TRANSOBTUR2 KIT X1

    MDR report key: 2250074 · Received September 9, 2011

    Report

    Report Number
    9615742-2011-00075
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    May 24, 2007
    Report Date
    August 10, 2011
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MDR REF #: 9615742-2011-00074 (AVAULTA POSTERIOR) 9615742-2011-00078 (AVAULTA ANTERIOR). NOTE: THIS REPORT CORRESPONDS WITH BARD'S REPORT (B)(4) FOR AN "URETEX".

    Description of Event or Problem · 1

    PROCEDURE: UROLOGICAL / GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT UNDERWENT AN ANTERIOR AND POSTERIOR REPAIR PROCEDURE FOR TREATMENT OF PELVIC ORGAN PROLAPSE. THE PT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URETEX SUPPORT PP TRANSOBTUR2 KIT X1 URETEX SUPPORT SYSTEM FTL SOFRADIM PRODUCTION SGL00473

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention