BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSORBA COLUMN

    MDR report key: 484418 · Received September 16, 2003

    Report

    Report Number
    3032792-2003-00005
    Event Type
    Injury
    Date Received
    September 16, 2003
    Date of Event
    July 23, 2003
    Report Date
    September 15, 2003
    Manufacturer
    FRESENIUS HEMOCARE, INC.
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED TREATMENT 90 IN 07/2003. PATIENT WAS ADMITTED TO HOSPITAL IN 2003 WITH SYMPTOMS OF DECREASED CIRCULATION TO THE LOWER EXTREMITIES. PATIENT WAS RELEASED AFTER 3 DAYS WITH DIAGNOSIS OF "BLOCKED AORTA" (PER PATIENT). FHC WAS UNABLE TO OBTAIN CONFIRMATION OF DIANOSIS UNTIL 9/03 WHEN CO RECEIVED A COPY OF A DISCHARGE SUMMARY WHICH STATED THE PATIENT HAD "PARTIAL AORTIC OCCLUSION AS WELL AS MULTIPLE STENOTIC LEIONS INFRARENALLY WHICH APPEARED TO BE CHRONIC, WITH EXTENSIVE PELVIC COLLATERALIZAITON AND RECONSITITUION OF ILIACS." THE RHEUMATOLOGIST HAD RELAYED THAT THE CONDITION APPEARED TO BE "SILENT AND LONGSTANDING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSORBA COLUMN PROSORBA COLUMN LQQ FRESENIUS HEMOCARE, INC. 9798701 PCN001A

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization ASPIRIN, BISOPROLOL, ABENZA, NEXIUM.