BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX ENTERAL DUODENAL STENT

    MDR report key: 1328278 · Received February 27, 2009

    Report

    Report Number
    3005099803-2009-00872
    Event Type
    Injury
    Date Received
    February 27, 2009
    Report Date
    January 30, 2009
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD.
    Product Code
    MUM
    PMA / PMN Number
    K062750
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE ARE UNK SINCE THE LOT NUMBER IS UNK. THE DEVICE IS NOT AVAILABLE. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    NOTE: DATE OF EVENT IS UNK. ON JANUARY 30, 2009, A BOSTON SCIENTIFIC EMPLOYEE BECAME AWARE OF A CLINICAL STUDY ARTICLE, "COMBINED ENDOSCOPIC STENT INSERTION IN MALIGNANT BILIARY AND DUODENAL OBSTRUCTION", BY M. MUTIGNANI, ET AL. ACCORDING TO THE ARTICLE, THE WALLFLEX ENTERAL DUODENAL STENT WAS USED IN A COMBINED ENDOSCOPIC STENT INSERTION. WITHIN SEVEN DAYS AFTER STENT INSERTION, THE PT EXPERIENCED ACUTE CHOLECYSTITIS. THERE IS NO FURTHER INFO FROM THE ARTICLE REGARDING THE STATUS OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ENTERAL DUODENAL STENT MUM BOSTON SCIENTIFIC IRELAND, LTD. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other