BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROSORBA COLUMN

    MDR report key: 772722 · Received October 18, 2006

    Report

    Report Number
    3032792-2006-00014
    Event Type
    Other
    Date Received
    October 18, 2006
    Date of Event
    September 17, 2006
    Report Date
    October 18, 2006
    Manufacturer
    FRESENIUS HEMOCARE
    Product Code
    LQQ
    PMA / PMN Number
    p850020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS A CLINICAL INVESTIGATION ONLY. RETURN OF PRODUCT NOT REQUESTED AS EVALUATION OF DEVICE AFTER USE NOT RELEVANT TO REPORTED EVENT. THE DEVICE WAS USED ACCORDING TO LABELED INDICATIONS AND IN THE APPROPRIATE ENVIRONMENT. TEMPORAL RELATIONSHIP OF THE EVENT AND PROSORBA MIGHT SUGGEST A CONTRIBUTORY RELATIONSHIP.

    Description of Event or Problem · 1

    PATIENT HOSPITALIZED SIX DAYS AFTER HIS FOURTH PROSORBA TREATMENT WITH A RASH/SORES ON SEVERAL PARTS OF HIS BODY. HE WAS ADMINISTERED ANTIBIOTIC, BIOPSIES AND CULTURES WERE PERFORMED. FHC WAS INFORMED THAT A CULTURE WAS POSITIVE FOR STREP, HOWEVER, NO SOURCE WAS FOUND. WE HAVE BEEN UNABLE TO OBTAIN BIOPSY RESULTS AT THIS TIME. THIS PATIENT HAD BEEN CONCURRENTLY TREATED FOR A "HEALING" MRSA INFECTION ON HIS HAND AT THE TIME THIS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSORBA COLUMN IMMUNOADSORPTION COLUMN LQQ FRESENIUS HEMOCARE 9798701 RGN001C

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization FENTANYL| HCTZ| KINERET| METHOTREXATE| PLAQUINIL| CYMBALTA| OXYCONTIN