BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSORBA COLUMN

    MDR report key: 367189 · Received December 17, 2001

    Report

    Report Number
    3032792-2001-00034
    Event Type
    Injury
    Date Received
    December 17, 2001
    Date of Event
    September 19, 2001
    Report Date
    December 17, 2001
    Manufacturer
    FRESENIUS HEMOCARE, INC.
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT DEVELOPED FEVER TO 104 DEGREES ON THE DAY AFTER THEIR 2ND COLUMN TREATMENT. PATIENT WAS HOSPITALIZED, ADMINISTERED ANTIBIOTICS AND THEIR CENTRAL VENOUS CATHETER WAS REMOVED. INITIAL BLOOD CULTURES WERE NEGATIVE, COMPANY UNABLE TO OBTAIN RESULTS FROM CATHETER TIP. PATIENT RESPONDED WELL TO TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56944 PROSORBA COLUMN IMMUNOADSORPTION COLUMN LQQ FRESENIUS HEMOCARE, INC. 9798701 121300C

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization