BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMMUNOSORBA COLUMN

    MDR report key: 671307 · Received February 3, 2006

    Report

    Report Number
    3033270-2006-00002
    Event Type
    Injury
    Date Received
    February 3, 2006
    Date of Event
    May 6, 2002
    Report Date
    February 3, 2006
    Manufacturer
    FRESENIUS HEMOCARE
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS MYASTHENIA GRAVIS RESPONDED WELL TO 6 MONTHS OF IA TREATMENT, BUT THEN DISPLAYED ATYPICAL NEUROLOGIC SYMPTOMS OF INTENTION TREMOR. MERCURY LEVELS FOUND TO BE 107 UG/L HG. NO INFORMATION WAS RECEIVED REGARDING MEDICAL INTERVENTION OR THE PT OUTCOME IN THIS INCIDENT. IT IS NOT KNOWN WHETHER SHE WAS HOSPITALIZED. ADVERSE EVENT OCCURRED OUTSIDE THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMUNOSORBA COLUMN IMMUNOADSORPTION COLUMN LQQ FRESENIUS HEMOCARE 9797200 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other