BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSORBA COLUMN

    MDR report key: 298829 · Received September 29, 2000

    Report

    Report Number
    3023288-2000-00010
    Event Type
    Injury
    Date Received
    September 29, 2000
    Date of Event
    August 29, 2000
    Manufacturer
    CYPRESS BIOSCIENCE, INC.
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PT WITH PT SEVERE "RA" REC'D 9 PROSORBA COLUMN TREATMENTS. FOUR DAYS AFTER LAST TREATMENT, THE PT DEVELOPED A RASH ON BOTH FEET, THIGHS, AND ARMS. A BIOPSY WAS POSITIVE FOR VASCULITIS. THE PT'S PHYSICIAN REPORTED THAT AT FIRST LESIONS APPEARED TO BEING FADING SO PT WITHHELD STERIOD THERAPY. ONE WEEK LATER A NEW SET OF LESIONS APPEARED AND THE PT WAS STARTED ON 40MG PREDNISONE QD. LAB RESULTS AT THAT TIME REVEALED INCREASED BUN AND CREATININE AND ABNORMAL URINALYSIS. PROSORBA COLUMN TREATMENTS WERE DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSORBA COLUMN PROTEIN A IMMUNOADSORPTION COLUMN LQQ CYPRESS BIOSCIENCE, INC. NA 032900B

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization GLUCOSAMINE CHRONDROITIN SUFATE, QUERCETIN,| PRBC, ENBREL, VIOXX, CALCIUM, FERROUS SULFATE,| (NUTRITIONAL SUPPLEMENT), MULTI VITAMINS.