BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IVS TUNNELLER DEVICE

    MDR report key: 2903624 · Received January 3, 2013

    Report

    Report Number
    6000141-2013-00001
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    March 16, 2005
    Report Date
    December 6, 2012
    Manufacturer
    BALLYMONEY - USS
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: UROLOGICAL/GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT UNDERWENT A REPAIR PROCEDURE AND THE PT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES. PER NOTICE, THE PT WAS IMPLANTED WITH AN OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM, IVS TUNNELLER AND GYNEMESH DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3596 UNKNOWN IVS TUNNELLER DEVICE IVS TUNNELLER DEVICE FTL BALLYMONEY - USS

    Patients

    Seq Age Sex Outcome Treatment
    1