BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX COVERED NG ESOPHAGEAL STENT

    MDR report key: 1032050 · Received April 9, 2008

    Report

    Report Number
    3005099803-2008-00337
    Event Type
    Injury
    Date Received
    April 9, 2008
    Date of Event
    February 6, 2008
    Report Date
    March 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD
    Product Code
    ESW
    PMA / PMN Number
    K032930
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO ADD'L COMPLAINTS HAVE BEEN REPORTED FOR THE LOT. THE FEB 2008 15-MONTH ULTRAFLEX ESOPHAGEAL STENT PROD FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, HAS BEEN REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORT 3005099803-2008-00338 FOR EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX COVERED NG ESOPHAGEAL STENT ESW ESW BOSTON SCIENTIFIC IRELAND, LTD M00513750 0009609482

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention