BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IVS TUNNELLER DEVICE

    MDR report key: 2943848 · Received January 30, 2013

    Report

    Report Number
    6000141-2013-00013
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    November 26, 2012
    Manufacturer
    BALLYMONEY - USS
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE LITERATURE: CHRYSOSTOMOU, A. THE MANAGEMENT OF STRESS URINARY INCONTINENCE USING TRANSOBTURATOR TAPES IN (B)(6). INTERNATIONAL JOURNAL OF GYNECOLOGY AND OBSTERICS. CONFERENCE: (B)(6) FEMALE PTS WERE DIAGNOSED WITH STRESS URINARY INCONTINENCE (SUI) AND INCLUDED IN THE STUDY. THE AIM OF THIS STUDY WAS TO ASSESS THE SAFETY AND EFFICACY OF THE TOT IN TREATING SUI. THERE WERE (B)(4) IVS-O (TYCO, (B)(4) ARIS (MENTOR-PORGES), (B)(4) MONARC (AMS), (B)(4) OBTRYX (BOSTON SCIENTIFIC), AND (B)(4) INTRAMESH (COUSIN) IMPLANTED. INTRA-OPERATIVE AND POST-OPERATIVE COMPLICATIONS WERE NOT DIRECTLY ATTRIBUTED TO ANY SPECIFIC DEVICE IN THE ARTICLE. THE INTRA-OP COMPLICATIONS OF BLADDER PERFORATION (B)(4) AND VAGINAL PERFORATION (B)(4) WERE REPORTED. THE POST-OPERATIVE COMPLICATIONS OF TAPE EROSION (B)(4), SLING FAILURE (B)(4), AND DE NOVO UI (B)(4) WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40128 IVS TUNNELLER DEVICE IVS TUNNELLER FTL BALLYMONEY - USS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other