BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSORBA COLUMN

    MDR report key: 376055 · Received February 8, 2002

    Report

    Report Number
    3032792-2002-00001
    Event Type
    Injury
    Date Received
    February 8, 2002
    Date of Event
    January 8, 2002
    Report Date
    February 8, 2002
    Manufacturer
    FRESENIUS HEMOCARE, INC.
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT DEVELOPED FEVER, CHILLS, CHEST PAIN AND AN INCREASE IN JOINT PAIN APPROXIMATELY 24 HOURS AFTER THEIR FIRST COLUMN TREATMENT. PATIENT WAS ADMITTED TO THE HOSPITAL AND DIAGNOSED WITH STAPH SEPSIS SECONDARY TO A CENTRAL LINE INFECTION. THE PATIENT WAS DISCHARGED HOME WITH ANTIBIOTICS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization PREDNISONE, ASPIRIN, AZATHIOPRINE, PRILOSEC.