BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX TO2 URETHRAL SUPPORT SYSTEM

    MDR report key: 3203786 · Received April 3, 2013

    Report

    Report Number
    1018233-2013-01103
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 8, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTN
    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. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-01088.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137562 URETEX TO2 URETHRAL SUPPORT SYSTEM OTN SOFRADIM PRODUCTION NA SIJ00159

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention AVAULTA SOLO ANTERIOR SYNTHETIC SUPPORT SYSTEM