BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEMINI PAIRED WIRE HELICAL BASKETS

    MDR report key: 845105 · Received March 30, 2007

    Report

    Report Number
    6000043-2007-00036
    Event Type
    Injury
    Date Received
    March 30, 2007
    Date of Event
    January 2, 2007
    Report Date
    March 5, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THE THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IN ADDITION, THE FEBRUARY 2007 15-MONTH COMPLAINT TREND REPORT FOR ALL 11MM GEMINI BASKET FAMILY FAILURE MODES WAS REVIEWED; NO ADVERSE TREND WAS NOTED. NO DATA POINTS EXCEED THE BSC ACTION LIMIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMINI PAIRED WIRE HELICAL BASKETS FFL FFL BOSTON SCIENTIFIC M0063301090 9109601

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention