BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROSORBA COLUMN

    MDR report key: 541487 · Received March 25, 2004

    Report

    Report Number
    3032792-2004-00001
    Event Type
    Other
    Date Received
    March 25, 2004
    Date of Event
    November 21, 2003
    Report Date
    March 24, 2004
    Manufacturer
    FRESENIUS HEMOCARE, INC.
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD STROKE-LIKE SYMPTOMS (WEAKNESS, SLURRED SPEECH), ON DAY AFTER PROSORBA TREATMENT. ADMITTED TO HOSP SEVERAL DAYS LATER FOR EVALUATION OF POSSIBLE STROKE. AFTER DISCHARGE, PT TOLD APHERESIS NURSE THEY HAD NO RESIDUAL SIDE EFFECTS AND WAS NOT SURE WHETHER THEY HAD A STROKE. AFTER MULTIPLE ATTEMPTS TO HAVE MEDICAL RELEASE FORM SIGNED, THE PT HAS NOW DECLINED. NO INFO REGARDING DIAGNOSIS OR TEST RESULTS DURING HOSP CAN BE OBTAINED. AFTER MULTIPLE ATTEMPTS TO OBTAIN MEDICAL RECORDS REGARDING THIS HOSPITALIZATION, FHC WAS INFORMED IN MARCH 2004 THAT THIS PT HAS REFUSED TO SIGN THE NECESSARY RELEASE FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSORBA COLUMN PROSORBA COLUMN LQQ FRESENIUS HEMOCARE, INC. 9798701 PDN001A

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization 1. LEVOTHYROXINE, 2. RANITIDINE, 3. ASCRIPTIN,| 10. DEXAMETHASONE.| 4. CARISOPRODOL, 5. METHADONE, 6. METHOTREXATE,| 7. FOLIC ACID, 8. ALPRAZOLAM, 9. PROCHLORPERAZINE,