BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOPAS

    MDR report key: 1944373 · Received December 16, 2010

    Report

    Report Number
    2183959-2010-00463
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 30, 2010
    Report Date
    December 16, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE (B)(6) IS AN INVESTIGATION TO TREAT FECAL INCONTINENCE WITH MESH SLING IMPLANTS. THE TOPAS MESH IS NOT MARKETED OR SOLD OUTSIDE OF THE STUDY. UNABLE TO CONFIRM IF THE EVENT IS RELATED TO A DEVICE MALFUNCTION, DEVICE REMAINS IMPLANTED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BECOME AVAILABLE REGARDING THIS ADVERSE EVENT, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    (B)(4). ON (B)(6) 2008, A NEW TOPAS SLING WAS IMPLANTED FOR TREATMENT OF PT'S FECAL INCONTINENCE IN A (B)(6) TO INVESTIGATE TREATMENT OF FECAL INCONTINENCE WITH MESH. THE PT HAS NOT HAD IMPROVEMENT OF HER FECAL INCONTINENCE, AND STATES 'MY SITUATION HAS GOTTEN WORSE INSTEAD OF BETTER SINCE MY SURGICAL PROCEDURE' AND THIS PT HAS ENDED HER PARTICIPATION IN THE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOPAS TOPAS SLING FTL AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability