BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX INTRODUCER NEEDLE X1

    MDR report key: 3131363 · Received May 20, 2013

    Report

    Report Number
    9615742-2013-00433
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    January 13, 2005
    Report Date
    April 22, 2013
    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).

    Description of Event or Problem · 1

    PROCEDURE TYPE: STRESS UI/PELVIC ORGAN PROLAPSE. ACCORDING TO THE REPORTER: THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. PELVISOFT WAS REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223366 URETEX INTRODUCER NEEDLE X1 URETEX SUPPORT FTL SOFRADIM PRODUCTION 24180ITO

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other URETEX SUPPORT PP TRANOBTUR KIT X1| URETEXTO| MFR: 07/01/2004| LOT NUMBER: 24198TO, EXP 07/31/2009