BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX URETHRAL SUPPORT SYSTEM

    MDR report key: 2842784 · Received October 14, 2011

    Report

    Report Number
    1018233-2011-00300
    Event Type
    Injury
    Date Received
    October 14, 2011
    Report Date
    September 15, 2011
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PT THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED SHE HAS EXPERIENCED EXPOSED MESH THAT HAD TO BE TRIMMED, PERSISTENT YEAST INFECTIONS, PAIN AND DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URETEX URETHRAL SUPPORT SYSTEM FTL FTL SOFRADIM PRODUCTION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention