BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO SEAL

    MDR report key: 3002715 · Received December 6, 2010

    Report

    Report Number
    3002715
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 29, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER ST JUDE 6 FR ANGIO SEAL APPLIED TO RIGHT FEMORAL ARTERY, RIGHT LEG COLD AND WITHOUT PULSES. PT TAKEN TO SURGERY AND PLASTIC FORIEGN BODY (1CM X 2CM X 1CM) REMOVED. LOOKS LIKE DEVICE ANCHOR IN ST JUDE INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO SEAL HEMOSTASIS DEVICE MGB ST. JUDE MEDICAL * 3142174

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention