BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IVS TUNNELLER DEVICE

    MDR report key: 2922123 · Received January 11, 2013

    Report

    Report Number
    6000141-2013-00004
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    May 16, 2005
    Report Date
    December 14, 2012
    Manufacturer
    BALLYMONEY - USS
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT ALLEGES EXPERIENCED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19130 IVS TUNNELLER DEVICE IVS TUNNELLER DEVICE FTL BALLYMONEY - USS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other