BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELL-PRO

    MDR report key: 244583 · Received October 13, 1999

    Report

    Report Number
    244583
    Event Type
    Injury
    Date Received
    October 13, 1999
    Date of Event
    August 19, 1999
    Report Date
    August 23, 1999
    Manufacturer
    NEXELL THEAPEUTICS, INC.
    Product Code
    GKT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SMALL BOWEL BIOPSY SHOWS PT'S DUODENAL MUCOSA WITH GRAFT VERSUS HOST DISEASE, GRADE 4. THREE DAYS LATER, PT DEVELOPED "CONTINUOUS" DIARRHEA WITH AT LEAST 14 BOWEL MOVEMENTS IN 24 HRS. AT THE SAME TIME AS THE DIARRHEA, PT HAD AT LEAST 10 EPISODES OF EMESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-PRO CELL SELECTION COLUMN GKT NEXELL THEAPEUTICS, INC. PRE-COLUMN, AUDIN COLUMN *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization