BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROSORBA COLUMN

    MDR report key: 180187 · Received July 28, 1998

    Report

    Report Number
    3023288-1998-00001
    Event Type
    Other
    Date Received
    July 28, 1998
    Date of Event
    June 29, 1998
    Report Date
    July 27, 1998
    Manufacturer
    CYPRESS BIOSCIENCE, INC.
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A 47 YEAR OLD FEMALE PT, DIAGNOSIS MONOCLONAL GAMMOPATHY, HAS BEEN RECEIVING COLUMN THERAPY ALTERNATELY WITH PLASMA EXCHANGE. COLUMN TREATMENTS (4) BEGAN ON 6/22 (LOT # 042998C), 6/24 (LOT # 042998C) 6/26 (LOT # 042998A) AND 06/29 (LOT # 042998F). DAY AFTER THE 4TH TREATMENT PATIENT PRESENTED WITH A RASH ON BOTH LOWER EXTREMITIES, COVERING MOST OF THE CALVES, ANKLES AND TOPS OF FEET. PAIN EXPERIENCED IN FEET ESPECIALLY THE RIGHT FOOT. RASH IN NON-PURITIC. SOME BLISTERING NOTED. BIOPSY CONFIRMED CLINICAL DIAGNOSIS OF VASCULITIS. PT PLACED ON PREDNISONE TO TREAT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSORBA COLUMN PROTEIN A IMMUNOADSORPTION COLUMN LQQ CYPRESS BIOSCIENCE, INC. NA 042998F

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other