BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IVS TUNNELLER

    MDR report key: 1022019 · Received March 31, 2008

    Report

    Report Number
    6000141-2008-00003
    Event Type
    Injury
    Date Received
    March 31, 2008
    Report Date
    June 17, 2005
    Manufacturer
    BALLYMONEY - USS
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: INTRAVAGINAL SLING. ACCORDING TO THE REPORT: THERE WAS A ENTEROCELE POST-OP WHICH RESULTED IN A VAGINAL HERNIA. THE SEVERITY WAS MODERATE. THERE WAS NO MEDICATION ADMINISTERED, NO REMOVAL OF THE TAPE, HOWEVER, THERE WAS A FOLLOW-UP PROCEDURE, LAPAROSCOPIC SACROCOLPOPEXY, IN 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVS TUNNELLER SURGICAL MESH FTL BALLYMONEY - USS O4F248

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention