BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP KIT X1

    MDR report key: 3131311 · Received May 17, 2013

    Report

    Report Number
    9615742-2013-00431
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    June 8, 2009
    Report Date
    December 16, 2015
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTN
    PMA / PMN Number
    K012949
    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

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. AVAULTA SOLO ANTERIOR SYNTHETIC SUPPORT SYSTEM WAS REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220141 URETEX SUPPORT PP KIT X1 URETEX SUPPORT OTN SOFRADIM PRODUCTION SFA00402

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Other