BEUDAMED
    FDA Adverse Event Summary report: N

    ANGIOSEAL

    MDR report key: 2071000 · Received April 25, 2011

    Report

    Report Number
    2071000
    Date Received
    April 25, 2011
    Date of Event
    May 20, 2009
    Report Date
    April 25, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC
    Product Code
    MGB
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AT THE REQUEST OF THE PATIENT. IT IS HIS CONTENTION THAT AN ANGIO SEAL USED TO DURING HIS CARDIAC CATHERIZATION LEAD TO A PSEUDOANEURYSM THAT HAD TO BE EVACUATED EIGHT (8) DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOSEAL DEVICE, VASCULAR, HEMOSTASIS MGB ST. JUDE MEDICAL, INC * 2738792

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR CARDIAC DRUGS