BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHETIC SLING MESH

    MDR report key: 840381 · Received April 18, 2007

    Report

    Report Number
    2183959-2007-00009
    Event Type
    Injury
    Date Received
    April 18, 2007
    Date of Event
    March 30, 2006
    Report Date
    April 18, 2007
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED ON 3/19/2007 INDICATES THAT THE INVANCE DEVICE WAS IMPLANTED IN 2006 AND THEN REMOVED FIFTEEN DAYS LATER DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHETIC SLING MESH SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC. * NI

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R