BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 1564940 · Received November 18, 2009

    Report

    Report Number
    2183959-2009-00149
    Event Type
    Malfunction
    Date Received
    November 18, 2009
    Date of Event
    October 22, 2009
    Report Date
    December 17, 2009
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFO WE REC'D ON 11/19/2009 INDICATES A UNK MALE SLING WAS REMOVED ON (B) (6) 2009. AMS HAS REQUESTED REASON AND ADD'L INFO. NO FURTHER INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R