BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 2170942 · Received July 12, 2011

    Report

    Report Number
    2170942
    Date Received
    July 12, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 12, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MND
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    RESOLUTION CLIP FAILED TO DEPLOY IN A CONTROL BLEED SITUATION. SMALL BOWEL PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * RESOLUTION CLIP MND BOSTON SCIENTIFIC * 1ML 1021401

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR