BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSORBA COLUMN

    MDR report key: 611110 · Received June 3, 2005

    Report

    Report Number
    3032792-2005-00009
    Event Type
    Injury
    Date Received
    June 3, 2005
    Date of Event
    April 7, 2005
    Report Date
    June 3, 2005
    Manufacturer
    FRESENIUS HEMOCARE
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED TO HOSP THREE WEEKS AFTER THEIR LAST PROSORBA COLUMN TREATMENT WITH SYMPTOMS OF FEVER, CHILLS, "MILD UPPER RESPIRATORY TRACT-TYPE SYMPTOMS" AND DECREASED APPETITE. THEY WERE FOUND TO HAVE AN INCREASED WBC COUNT AND ANEMIA. HOSP DISCHARGE SUMMARY DESCRIBED THEIR CONDITION AS A "BRONCHITIS-TYPE PICTURE" WITH POSSIBLE RA EXACERBATION. THEY WERE TREATED WITH ANTIBIOTICS, TRANSFUSED AND GIVEN PAIN MEDICATION AND REFERRED BACK THEIR INTERNIST FOR F/U AND POSSIBLE GI WORKUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSORBA COLUMN PROSORBA COLUMN LQQ FRESENIUS HEMOCARE 9798701 QHN001D

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization