BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSORBA COLUMN

    MDR report key: 359791 · Received October 24, 2001

    Report

    Report Number
    3032792-2001-00031
    Event Type
    Injury
    Date Received
    October 24, 2001
    Date of Event
    October 4, 2001
    Report Date
    October 23, 2001
    Manufacturer
    FRESENIUS HEMOCARE, INC.
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A RHEUMATOID ARTHRITIS PATIENT DEVELOPED CHEST PAIN DURING THE PT'S FIFTH TREATMENT. DIAGNOSED WITH ACUTE MI. HOSPITALIZED FOR THREE DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47832 PROSORBA COLUMN IMMUNOADSORPTION COLUMN LQQ FRESENIUS HEMOCARE, INC. 9798701 022801F

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization CELEBREX, AVAPRO, EULEXIN, 5FU, LEUKOVORIN AND "A| NEW TRIAL DRUG FOR CANCER."