BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP KIT X1

    MDR report key: 2941579 · Received January 17, 2006

    Report

    Report Number
    9615742-2013-00037
    Event Type
    Injury
    Date Received
    January 17, 2006
    Date of Event
    October 17, 2005
    Report Date
    December 20, 2012
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K012949
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION FROM THE IMPORTER REPORT: (B)(6) /2012; URETEX SUP URETHRAL SUPPORT SYSTEM; CATALOG # 485013; (B)(6). ATTORNEY.

    Description of Event or Problem · 1

    PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. ADDITIONAL INFORMATION FROM THE IMPORTER REPORT: ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URETEX SUPPORT PP KIT X1 URETEX SUPPORT FTL SOFRADIM PRODUCTION NA SFD00032

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other| R