BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSORBA COLUMN

    MDR report key: 292351 · Received August 24, 2000

    Report

    Report Number
    3023288-2000-00008
    Event Type
    Injury
    Date Received
    August 24, 2000
    Date of Event
    July 25, 2000
    Report Date
    August 24, 2000
    Manufacturer
    CYPRESS BIOSCIENCE, INC.
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PT WITH SEVERE RHEUMATOID ARTHRITIS REC'D 6 PROSORBA COLUMN TREATMENTS. THE PT WAS HOSPITALIZED 24 TO 48 HOURS AFTER LAST TREATMENT. A DIAGNOSIS OF 5 PULMONARY EMBOLI WAS MADE WITH UNKNOWN LOCATION OF ORIGINATING CLOT. PT HAS NO KNOWN HISTORY OF HYPERCOAGUABLE EVENTS. THERE IS NO RECORD OF ANTIPHOSPHOLIPID TESTING PRIOR TO TREATMENT. PT WAS SUBSEQUENTLY DISCHARGED ON COUMADIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSORBA COLUMN PROTEIN A IMMUNOADSORPTION COLUMN LQQ CYPRESS BIOSCIENCE, INC. NA 020800A

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization 5. CYTOTEC,| 1. NEURONTIN,| 7. NORVASC.| 3. VIOXX,| 4. IMMURAN,| 6. DARVOCET,| 2. PREDNISONE,