BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELLEX LIGHT ASSEMBLY

    MDR report key: 4540752 · Received February 18, 2015

    Report

    Report Number
    MW5040832
    Event Type
    Injury
    Date Received
    February 18, 2015
    Report Date
    February 18, 2015
    Manufacturer
    THERAKOS INC.
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE SETTING-UP THE CELLEX PHOTOPHERESIS DEVICE, LAMP FAILURE ALARM OCCURRED WHILE THERE WERE 54 HOURS REMAINING ON THE LAMP LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116225 CELLEX LIGHT ASSEMBLY PHOTOPHERESIS LAMP LNR THERAKOS INC. CELLEX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention