BEUDAMED
    FDA Adverse Event Other Summary report: N

    I M P SPHINCTER AMS 800

    MDR report key: 709871 · Received May 5, 2006

    Report

    Report Number
    709871
    Event Type
    Other
    Date Received
    May 5, 2006
    Date of Event
    May 3, 2006
    Report Date
    May 5, 2006
    Manufacturer
    AMERICAN MED SYSTEMS
    Product Code
    EZY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NON FUNCTIONAL ARTIFICIAL URINARY SPHINCTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I M P SPHINCTER AMS 800 ARTIFICIAL URINARY SPHINCTER EZY AMERICAN MED SYSTEMS 724000-98 435760017

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other