BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUP URETHRAL SUPPORT SYSTEM

    MDR report key: 3152201 · Received May 16, 2013

    Report

    Report Number
    1018233-2013-02028
    Event Type
    Injury
    Date Received
    May 16, 2013
    Report Date
    March 16, 2016
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    (B)(4). THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET REC'D. ASSOCIATED MDR: 1018233-2013-01781.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216521 URETEX SUP URETHRAL SUPPORT SYSTEM Mesh, surgical, polymeric FTL SOFRADIM PRODUCTION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - ANTERIOR| AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - POSTERIOR| AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - ANTERIOR