BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUP URETHRAL SUPPORT SYSTEM

    MDR report key: 3152162 · Received May 29, 2013

    Report

    Report Number
    1018233-2013-02272
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    April 30, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    COMPLAINT #(B)(4). THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PER ADD'L INFO RECEIVED, THE PT HAS EXPERIENCED INADEQUATELY CONTROLLED POSTOPERATIVE PAIN AND URINE RESIDUAL OF 270CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233615 URETEX SUP URETHRAL SUPPORT SYSTEM OTN SOFRADIM PRODUCTION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention