BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1231123 · Received November 12, 2008

    Report

    Report Number
    3005099803-2008-06401
    Event Type
    Malfunction
    Date Received
    November 12, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IN 2008, BOSTON SCIENTIFIC CORPORATION WAS INFORMED THAT DURING A PROCEDURE, A RESOLUTION CLIP DEVICE CLIP WOULD NOT OPEN. PATIENT IS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE MND BOSTON SCIENTIFIC CORPORATION M00522600 0ML7010302

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR