BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHETIC SLING MESH

    MDR report key: 1242308 · Received November 20, 2008

    Report

    Report Number
    2183959-2008-00024
    Event Type
    Injury
    Date Received
    November 20, 2008
    Report Date
    November 19, 2008
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED ON 11/18/08 FROM THE PATIENT REPORTED AN "UNSUCCESSFUL RESULT" FROM HIS IN VANCE PLACEMENT ON LAST YEAR. A REVISION SURGERY HAS NOT BEEN DETERMINED AT THIS TIME.

    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 Disability