BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLEX 300I (PT ENROLLED ON STUDY W/IDE#BB-IDE 6474

    MDR report key: 375104 · Received January 25, 2002

    Report

    Report Number
    MW1023985
    Event Type
    Injury
    Date Received
    January 25, 2002
    Date of Event
    January 23, 2002
    Report Date
    January 25, 2002
    Manufacturer
    NEXELL THERAPEUTICS INC
    Product Code
    GKT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT IS 45 DAYS POST AUTOLOGOUS STEM CELL TRANSPLANT. PT WAS READMITTED TO HOSP IN HOME TOWN WITH SHORTNESS OF BREATH, NONPRODUCTIVE COUGH AND WEIGHT GAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLEX 300I (PT ENROLLED ON STUDY W/IDE#BB-IDE 6474 CELL SEPARATION GKT NEXELL THERAPEUTICS INC 3001 H97F19X72R

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization TBI, CYCLOPHOSPHAMIDE, ATG 12/5/01-12/15/01.