BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IVS TUNNELLER

    MDR report key: 3093915 · Received April 24, 2013

    Report

    Report Number
    6000141-2013-00039
    Event Type
    Injury
    Date Received
    April 24, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    BALLMONEY 0 USS
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: TYCO MESH WAS REMOVED DUE TO AN EXTRUSION OF MESH PLACED OVER EIGHT YEARS AGO. THE MESH WAS IMPLANTED ON (B)(6) 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176440 IVS TUNNELLER IVS TUNNELLER FTL BALLMONEY 0 USS O4F248

    Patients

    Seq Age Sex Outcome Treatment
    1 Other