BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1203196 · Received October 17, 2008

    Report

    Report Number
    3005099803-2008-05376
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Report Date
    September 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DATE IS UNKNOWN. ON SEPTEMBER 19, 2008, BOSTON SCIENTIFIC CORPORATION WAS INFORMED THAT DURING AN UPPER HEMOSTASIS PROCEDURE, A RESOLUTION CLIP DEVICE WOULD NOT DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT PATIENT COMPLICATIONS. PATIENT IS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE MND BOSTON SCIENTIFIC CORPORATION M00522611 0ML8021805

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK