BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 1022093 · Received March 27, 2008

    Report

    Report Number
    MW5006075
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    May 23, 2004
    Report Date
    March 27, 2008
    Manufacturer
    ST. JUDES
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ANGIO-SEAL USED FOR HEART CATH CLOSURE. HEART CATH NORMAL. SWELLING AND PAIN IN GROIN IMMEDIATELY AFTER CATH, ULTRASOUND REVEALED AN AV FISTULA, HEAVY BLEEDING. REPAIRED USING GORTEX-GRAFT, STAPH INFECTION REQUIRING MONTHS OF HOME IV TREATMENT. GRAFT FAILED WITHIN 6 MONTHS, FEMORAL BY-PASS PERFORMED TO REPAIR. SEVERE PAIN AND NUMBNESS STILL PROBLEMATIC. THERE ARE EXPERTS OUT THERE WHO ARE AWARE OF THE PROBLEMS WITH THIS DEVICE, WHY IS IT STILL ON THE MARKET MAIMING AND KILLING INNOCENT PEOPLE?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL NONE MGB ST. JUDES

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| L| O| R| S