BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSORBA COLUMN

    MDR report key: 360830 · Received November 9, 2001

    Report

    Report Number
    3032792-2001-00033
    Event Type
    Injury
    Date Received
    November 9, 2001
    Date of Event
    October 11, 2001
    Report Date
    November 9, 2001
    Manufacturer
    FRESENIUS HEMOCARE, INC.
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RHEUMATIOD ARTHRITIS PATIENT DEVELOPED A COLD RIGHT LEG AND ABDOMINAL PAIN APPROXIMATELY 5 HOURS AFTER 5TH COLUMN TREATMENT. THE PATIENT WAS HOSPITALIZED AND DIAGNOSED WITH THROMBOSIS OF SUPERIOR MESENTERIC ARTERY AND RIGHT TIBIAL ARTERY. A PARTIAL BOWEL RESECTION WAS PERFORMED. THIS PATIENT HAD A HISTORY OF DVT 1 YEAR AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50586 PROSORBA COLUMN IMMUNOADSORPTION LQQ FRESENIUS HEMOCARE, INC. 9798701 022801G

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization ROFECOXIB, PREDNISONE, HCTZ, SERTRALINE| HYDROCHLORIDE, ALPRAZOLAM, ZOLPIDEM TARTRATE.