BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUP URETHRAL SUPPORT SYSTEM

    MDR report key: 3221141 · Received May 17, 2013

    Report

    Report Number
    1018233-2013-02092
    Event Type
    Injury
    Date Received
    May 17, 2013
    Report Date
    April 19, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    (B)(4). THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PER ADDITIONAL INFO RECEIVED, THE PT HAS EXPERIENCED THIRD-DEGREE RECTOCELE, THIRD-DEGREE CYSTOCELE, AND STRESS URINARY INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219809 URETEX SUP URETHRAL SUPPORT SYSTEM OTN SOFRADIM PRODUCTION NA C24201SUP

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention