BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX TO URETHRAL SUPPORT SYSTEM

    MDR report key: 3172273 · Received April 25, 2013

    Report

    Report Number
    1018233-2013-01561
    Event Type
    Injury
    Date Received
    April 25, 2013
    Report Date
    October 21, 2015
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180733 URETEX TO URETHRAL SUPPORT SYSTEM OTN SOFRADIM PRODUCTION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention