BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSORBA COLUMN

    MDR report key: 611089 · Received June 3, 2005

    Report

    Report Number
    3032792-2005-00010
    Event Type
    Injury
    Date Received
    June 3, 2005
    Date of Event
    March 24, 2005
    Report Date
    April 7, 2005
    Manufacturer
    FRESENIUS HEMOCARE
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED TO HOSP AFTER SECOND PROSORBA TREATMENT WITH FEVER AND "NOT FEELING WELL". PT WAS TOLD THERE WAS A CLOT ABOVE THE CATHETER. THE CATHETER WAS REMOVED AND PT WAS DISCHARGED ON COUMADIN AND ANTIBIOTICS. NO FURTHER PROSORBA TREATMENT.

    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 60 YR Hospitalization