BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX COVERED NG ESOPHAGEAL STENT

    MDR report key: 1171316 · Received September 17, 2008

    Report

    Report Number
    3005099803-2008-04630
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    July 28, 2008
    Report Date
    August 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    ESW
    PMA / PMN Number
    K032930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON OPENING THE PACKAGE OF THE ULTRAFLEX ESOPHAGEAL 23MM X 12MM STENT DELIVERY SYSTEM (SDS), THE DEVICE WAS "NOT IN CONDITION TO BE USED". IT WAS NOT KNOWN HOW THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX COVERED NG ESOPHAGEAL STENT ESW PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC M00514210 9480387

    Patients

    Seq Age Sex Outcome Treatment
    1