BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 2140543 · Received June 17, 2011

    Report

    Report Number
    MW5021115
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    October 13, 2010
    Report Date
    June 13, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ANGIO-SEAL DEVICE INSERTED INTO RIGHT FEMORAL ARTERY AFTER ANGIOGRAM PERFORMED. A DEEP VEIN THROMBOSIS DEVELOPED WITHIN DAYS IN MY RIGHT THIGH. I WAS HOSPITALIZED FOR 1 WEEK AND GIVEN LOVENOX AND COUMADIN FOR CLOTTING. I HAVE NEVER HAD ANY CIRCULATION PROBLEMS PREVIOUSLY. ALSO I HAVE SEVERE PAIN IN THE AREA OF THE ANGIO-SEAL FOR LAST 6 MONTHS AND DR. SAYS "OH! THAT'S NORMAL, IT WILL GO AWAY." I BELIEVE THE ANGIO SEAL CAUSED THE D.V.T. AND I AM LEFT W/EXCRUCIATING PAIN IN RIGHT GROIN AREA. ALSO, I CONTINUE TO TAKE COUMADIN FOR THE CLOT IN LEG STILL THERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL VASCULAR CLOSURE DEVICE MGB ST. JUDE MEDICAL F00038205608

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| S