BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPHINCTER 800 URINARY PROSTHESIS

    MDR report key: 2581246 · Received May 15, 2012

    Report

    Report Number
    2183959-2012-00651
    Event Type
    Injury
    Date Received
    May 15, 2012
    Date of Event
    December 17, 2011
    Report Date
    February 7, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FAG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CATALOG #: 72400024, 72404127. ADDITIONAL SERIAL NUMBERS: (B)(4). THE DEVICE PERFORMED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE DEVICE WAS REMOVED DUE TO EROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS SPHINCTER 800 URINARY PROSTHESIS ARTIFICIAL URINARY SPHINCTER FAG AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R