BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1230523 · Received November 12, 2008

    Report

    Report Number
    3005099803-2008-06411
    Event Type
    Injury
    Date Received
    November 12, 2008
    Report Date
    October 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE SUSPECT DEVICE IS UNKNOWN; THEREFORE, THE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED. THE SUSPECT DEVICE IS NOT AVAILABLE FOR ANALYSIS. A DEVICE EVALUATION WILL NOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    EVENT DATE IS UNKNOWN. IN 2008, BOSTON SCIENTIFIC CORPORATION WAS INFORMED THAT THE PATIENT STILL HAS CLIPS PRESENT SIX WEEKS POST-PROCEDURE. PATIENT IS "OKAY".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other