BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSORBA COLUMN

    MDR report key: 479885 · Received August 21, 2003

    Report

    Report Number
    3032792-2003-00004
    Event Type
    Injury
    Date Received
    August 21, 2003
    Date of Event
    July 21, 2003
    Report Date
    August 21, 2003
    Manufacturer
    FRESENIUS HEMOCARE, INC.
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED TO THE HOSP THE EVENING AFTER THE 10TH PROSORBA TREATMENT. PT WAS DIAGNOSED WITH A LEFT HEMISPHERE STROKE. PT WAS DISCHARGED HOME AFTER APPROX 4 DAYS WITH NO RESIDUAL SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSORBA COLUMN PROSORBA COLUMN LQQ FRESENIUS HEMOCARE, INC. 9798701 PCN001A

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization AVAPRIL (WOULD NOT TAKE FOR TWO DAYS PRIOR TO EACH| TREATMENT).| EVISTA, GLUCOPHAGE, CALCIUM, ASPIRIN, CELEBREX,