BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMMUNOSORBA COLUMN

    MDR report key: 539822 · Received August 16, 2004

    Report

    Report Number
    3033270-2004-00001
    Event Type
    Injury
    Date Received
    August 16, 2004
    Date of Event
    July 20, 2004
    Report Date
    August 16, 2004
    Manufacturer
    FRESENIUS HEMOCARE, INC.
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    USER ERROR CAUSED INFUSION OF STORAGE SOLUTION TO PT RESULTING IN ELEVATED MERCURY LEVELS. PT ASYMPTOMATIC AND BEING TREATED WITH CHELATING AGENTS TO REMOVE MERCURY. AWAITING FURTHER FOLLOW-UP. APHERESIS OPERATORS VERY AWARE OF ERROR MADE AND HAVE RECEIVED NECESSARY TRAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMUNOSORBA COLUMN IMMUNOSORBA COLUMN LQQ FRESENIUS HEMOCARE, INC. 9797200 PGL003C

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention