BEUDAMED
    FDA Adverse Event Death Summary report: N

    UVAR XTS PHOTOPHERESIS SYSTEM

    MDR report key: 685646 · Received March 8, 2006

    Report

    Report Number
    2523595-2006-00002
    Event Type
    Death
    Date Received
    March 8, 2006
    Date of Event
    February 3, 2004
    Report Date
    March 3, 2006
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS LITERATURE CASE IN CORYNEBACTERIUM JEIKEIUM SEPIS AFTER 8- METHOXYPSOLAREN PHOTOPHERESIS FOR CUTANEOUS T-CELL LYMPOHOMA CONCERNS A MALE PT. THE PT MEDICAL HISTORY INCLUDED TYPE 2 DIABETES MELLITUS, HYPERTENSION, HYPERLIPIDEMIA, PARKINSON'S DISEASE, AND CHRONIC ANEMIA. THE PT CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PT RECEIVED 8- METHOXYPSOLAREN PHOTOPHERESIS (8-MOP) FOR CUTANEOUS T- CELL LYMPHOMA WITH LONG-WAVE ULTRAVIOLET REDIATION (ECP) FOR TREATMENT OF CUTANEOUS T-CELL LYMPHOMA (CTCL). ONE WEEK AND 3 WEEKS PRECEDING TREATMENT WITH 8-MOP THE PT WAS ADMITTED WITH WEAKNESS, DIARRHEA, HYPOTENSION AND ALTERED MENTAL STSTUS. ACTION TAKEN WITH SUSPECT DRUG WAS NOT REPORTED. THE PT WAS FREE OF RECURRENT C. JEIKEIUM INFECTION BUT DIED FORM REFRACTORY T-CELL LYMPHOMA 3 MONTHS LATER. NO CAUSALITY STATEMENT WAS PROVIDED BY THE REPORTER, BUT THE EVENT IS CONSIDERED TO BE RELATED TO 8-MOP AS THE EVENT WAS REPORTED IN A LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UVAR XTS PHOTOPHERESIS SYSTEM PHOTOPHERESIS PROCEDURAL KIT LNR THERAKOS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization