BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTASURE REMEEX SYSTEM, FEMALE

    MDR report key: 2426741 · Received January 16, 2012

    Report

    Report Number
    2426741
    Event Type
    Injury
    Date Received
    January 16, 2012
    Date of Event
    January 10, 2012
    Report Date
    January 16, 2012
    Manufacturer
    NEOMEDIC INTERNATIONAL
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD IMPLANTATION OF MID URETHRAL SLING APPROX 2 YEARS AGO PREDOMINANTLY FOR STRESS INCONTINENCE AND INTRINSIC SPHINCTER DEFICIENCY. APPROXIMATELY 7 MONTHS FOLLOWING THE PROCEDURE, PATIENT EXPERIENCED 0.5 CM OF EXPOSED WHITE MESH DIRECTLY BEHIND URETHRAL MEATUS. DUE TO CONTINUED MESH EROSION, PATIENT RECENTLY RETURNED TO SURGERY FOR " REMOVAL OF MID URETHRAL SLING CONTASURE REMEEX SLING AND CONTROLLER BOX."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTASURE REMEEX SYSTEM, FEMALE VAGINAL SLING FTL NEOMEDIC INTERNATIONAL SREM01 20090330

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R