BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSORBA COLUMN

    MDR report key: 385457 · Received March 29, 2002

    Report

    Report Number
    3032792-2002-00002
    Event Type
    Injury
    Date Received
    March 29, 2002
    Date of Event
    February 28, 2002
    Report Date
    March 28, 2002
    Manufacturer
    FRESENIUS HEMOCARE, INC.
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PATIENT CONTACTED COMPANY TO INFORM COMPANY THAT THEY DEVELOPED PURPURA ON LOWER LEGS AFTER 2 COLUMN TREATMENTS LAST OCTOBER. IT RESOLVED WITH STEROIDS BUT THEN PATIENT DEVELOPED FLUID RETENTION AND PROTEINURIA. PATIENT IS NOW UNDERGOING TREATMENT FOR MESANGIOPROLIFERATIVE GLOMERULONEPHRITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSORBA COLUMN IMMUNOADSORPTION LQQ FRESENIUS HEMOCARE, INC. 9798701 022801C

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention EFFEXOR.| LASIX, METHADONE, PRINIVIL, PROTONIX, ZANAX,