BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUP URETHRAL SUPPORT SYSTEM

    MDR report key: 3192791 · Received May 1, 2013

    Report

    Report Number
    1018233-2013-01625
    Event Type
    Injury
    Date Received
    May 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET REC'D. ASSOCIATED MDR: 1018233-2013-01626 AND 01624.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190944 URETEX SUP URETHRAL SUPPORT SYSTEM FTL SOFRADIM PRODUCTION NA SGF00797

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM| AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM