BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANGIO-SEAL

    MDR report key: 1002423 · Received February 5, 2008

    Report

    Report Number
    MW5005634
    Event Type
    Other
    Date Received
    February 5, 2008
    Date of Event
    November 14, 2007
    Report Date
    February 5, 2008
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    MGB
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2007, I HAD A SEVERE REACTION TO A PRODUCT CALLED ANGIO-SEAL. IT IS A COLLAGEN COMPOUND WHICH IS INSERTED INTO THE FEMORAL ARTERY AFTER AN ANGIOGRAM. IT IS MADE BY ST JUDE MEDICAL. I HAD AN ANGIOGRAM AT THE MEDICAL CENTER, ANOTHER STATE ON THE DAY BEFORE. THE NEXT DAY, I WOKE UP WITH BREATHING PROBLEMS, THEN GOT CHILLS AND UNCONTROLLABLE SHAKING. I WENT TO THE RMC EMERGENCY ROOM WHERE I WAS TREATED FOR SHOCK, VERY HIGH BLOOD PRESSURE AND ALLERGIC REACTION. I CONTINUED TO HAVE HAD ALLERGY SYMPTOMS FOR TWO MONTHS, SO I FINALLY CALLED ST JUDE MEDICAL AND TALKED TO A TECHNICIAN. I WAS TOLD THAT MY SYMPTOMS WERE PROBABLY TISSUE REJECTION, AND THAT IT TAKES ABOUT 90 DAYS FOR THE BODY TO ABSORB THE COLLAGEN AND THAT WITH MY MEDICAL HISTORY OF AUTOIMMUNE DISORDERS (LUPUS, HASHIMOTO'S AND SJOGRENS), I SHOULD NEVER HAVE HAD THE DEVICE IMPLANTED. MY HEART DOCTOR DID NOT DISCUSS THE USE OF THIS DEVICE AHEAD OF TIME - NOR HAS HE SEEN ME SINCE THE ANGIOGRAM. DR. I WENT TO THE FDA WEBSITE, BUT COULD NOT DETERMINE WHICH CATEGORY THIS DEVICE BELONGS IN, AND THE INCIDENCE REPORT FORM IS SO SMALL THAT I HAD TROUBLE READING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL COLLAGEN COMPOUND MGB ST JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 YR