BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOLEX STEM CELL REAGENT KIT

    MDR report key: 233302 · Received July 23, 1999

    Report

    Report Number
    2030437-1999-00002
    Event Type
    Malfunction
    Date Received
    July 23, 1999
    Date of Event
    June 24, 1999
    Report Date
    June 24, 1999
    Manufacturer
    NEXELL THERAPEUTICS INC.
    Product Code
    GKT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER COMPLETED ISOLEX 3001 PROCEDURE. UNABLE TO USE FINAL PRODUCT DUE TO CLUMPING. AS A RESULT, THE PATIENT HAS BEEN REMOBILIZED AND WILL BE RE-COLLECTED. INVESTIGATION IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLEX STEM CELL REAGENT KIT STEM CELL SELECTION SYSTEM GKT NEXELL THERAPEUTICS INC. ITX1030 2666T002AA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN