BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX PRECISION COLONIC STENT SYSTEM

    MDR report key: 1062942 · Received June 19, 2008

    Report

    Report Number
    3005099803-2008-00792
    Event Type
    Injury
    Date Received
    June 19, 2008
    Report Date
    May 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD.
    Product Code
    MQR
    PMA / PMN Number
    K000281
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    NOTE: EVENT DATE IS UNK. ON MAY 22, 2008, A BOSTON SCIENTIFIC EMPLOYEE BECAME AWARE OF A CLINICAL STUDY ARTICLE, "COMPARISON OF WALLSTENT AND ULTRAFLEX STENTS FOR PALLIATION OF MALIGNANT LEFT SIDED COLON OBSTRUCTION" PUBLISHED IN GASTROINTESTINAL ENDOSCOPY 67:3; 2008, PP 478-488 (SEE ATTACHED). THE STUDY WAS A RETROSPECTIVE ANALYSIS TO COMPARE WALLSTENT AND ULTRAFLEX STENTS. THE FOLLOWING INFO WAS DERIVED FROM THIS ARTICLE: ACCORDING TO THE ARTICLE, ON AN UNK DATE, LESS THAN SEVEN DAYS POST PLACEMENT OF THE ULTRAFLEX PRECISION COLONIC STENT SYS ON A PT, PT EXPERIENCED BACTERMIA/FEVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX PRECISION COLONIC STENT SYSTEM MQR BOSTON SCIENTIFIC IRELAND, LTD. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other