BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX TO2 URETHRAL SUPPORT SYSTEM

    MDR report key: 3221162 · Received May 17, 2013

    Report

    Report Number
    1018233-2013-02088
    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
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    (B)(4). THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-02087 AND 1018233-2013-02089.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220108 URETEX TO2 URETHRAL SUPPORT SYSTEM OTN SOFRADIM PRODUCTION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM| AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM