BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSORBA COLUMN

    MDR report key: 360826 · Received November 9, 2001

    Report

    Report Number
    3032792-2001-00032
    Event Type
    Injury
    Date Received
    November 9, 2001
    Date of Event
    October 4, 2001
    Report Date
    November 9, 2001
    Manufacturer
    FRESENIUS HEMOCARE, INC.
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RHEUMATIOD ARTHRITIS PATIENT HAD 4 COLUMN TREATMENTS USING PERIPHERAL STICKS. THE PATIENT THEN HAD A SUBCLAVIAN "UDAHL" CATHETER PLACED AND RECEIVED 5TH TREATMENT IN 2001. UPON RETURN 4 DAYS LATER FOR 6TH TREATMENT, LEFT ARM WAS SWOLLEN. TREATMENT WAS CANCELLED AND PATIENT SENT HOME. BY THE NEXT DAY SWELLING WAS WORSE, ARM TENDER AND PATIENT FEBRILE. THE PATIENT WAS ADMITTED TO HOSPITAL AND DIAGNOSED WITH VENOUS THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50513 PROSORBA COLUMN IMMUNOADSORPTION LQQ FRESENIUS HEMOCARE, INC. 9798701 051501F

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization NORVASC, HCTZ, PREDNISONE, ALBUTEROL, PERCOCET,| VIOXX, DURAGESIC PATCH, ASPIRIN.