BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX TO2 URETHRAL SUPPORT SYSTEM

    MDR report key: 3152176 · Received May 16, 2013

    Report

    Report Number
    1018233-2013-02042
    Event Type
    Injury
    Date Received
    May 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    SOFRADIM PRODUCTIONS
    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 INFORMATION RECEIVED, THE PT HAS EXPERIENCED A PUNCTURE HOLE IN THE VAGINA BY THE "INTRODUCER" AFTER UNDERGOING TRANSOBTURATOR TAPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216514 URETEX TO2 URETHRAL SUPPORT SYSTEM OTN SOFRADIM PRODUCTIONS NA SGI00374

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention