BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1296543 · Received December 5, 2008

    Report

    Report Number
    3005099803-2008-07004
    Event Type
    Malfunction
    Date Received
    December 5, 2008
    Report Date
    November 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    EVENT DATE IS UNKNOWN. IN 2008, BOSTON SCIENTIFIC CORP WAS INFORMED THAT WHILE UNPACKING THE RESOLUTION CLIP DEVICE, IT WAS NOTED THAT THE CLIP WAS OPENED. THE PRODUCT WAS NOT USED IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE MND BOSTON SCIENTIFIC CORPORATION M00522610 0ML8062507

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK