BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS BILIARY SD MONORAIL PREMOUNTED STENT SYSTEM

    MDR report key: 1000203 · Received June 8, 2007

    Report

    Report Number
    6000093-2007-01139
    Event Type
    Malfunction
    Date Received
    June 8, 2007
    Date of Event
    April 17, 2007
    Report Date
    May 10, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K040027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS BILIARY SD MONORAIL PREMOUNTED STENT SYSTEM FGE CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC NA 8021629

    Patients

    Seq Age Sex Outcome Treatment
    1 *