BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX

    MDR report key: 3121571 · Received May 10, 2013

    Report

    Report Number
    3121571
    Event Type
    Malfunction
    Date Received
    May 10, 2013
    Date of Event
    March 29, 2013
    Report Date
    May 9, 2013
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207678 CELLEX SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL & KIT LNR THERAKOS, INC. CELLEX B306/143

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR