BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT ENTERAL ENDOPROSTHESIS

    MDR report key: 1062956 · Received June 19, 2008

    Report

    Report Number
    3005099803-2008-00816
    Event Type
    Injury
    Date Received
    June 19, 2008
    Report Date
    May 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD.
    Product Code
    MQR
    PMA / PMN Number
    K000281
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MFR DATE IS UNK SINCE THE UPN AND LOT NUMBER WERE NOT ASCERTAINABLE FROM THE COMPLAINANT. THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    DURING A PRESENTATION AT THE 2008 DIGESTIVE DISEASE WEEK CONFERENCE, DATA WAS PRESENTED ON THE STUDY. A HEMOBILIA EVENT, WHICH INVOLVED A WALLSTENT ENTERAL ENDOPROSTHESIS DEVICE, OCCURRED IN A PT. NO ADD'L INFO WAS PROVIDED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT ENTERAL ENDOPROSTHESIS MQR BOSTON SCIENTIFIC IRELAND, LTD. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other