BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSORBA COLUMN

    MDR report key: 358474 · Received October 24, 2001

    Report

    Report Number
    3032792-2001-00030
    Event Type
    Injury
    Date Received
    October 24, 2001
    Date of Event
    August 9, 2001
    Report Date
    October 23, 2001
    Manufacturer
    FRESENIUS HEMOCARE, INC.
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT NOTICED VISUAL CHANGES AFTER THEIR 6TH TREATMENT. NEUROLOGY CONSULT DIAGNOSED RIGHT OCCIPITAL LOBE STROKE WITH LEFT INFERIOR QUADRANTANOPSIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47772 PROSORBA COLUMN IMMUNOADSORPTION COLUMN LQQ FRESENIUS HEMOCARE, INC. 9798701 080900C

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization CIMETIDINE.| AZATHIOPRINE, SULINDAC, HYDROCHLOROTHIAZIDE,| PREDNISONE, PLAQUENIL, MTX, CHROMAGEN,