BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM

    MDR report key: 2120130 · Received June 3, 2011

    Report

    Report Number
    2523595-2011-00017
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    May 24, 2011
    Report Date
    June 6, 2011
    Manufacturer
    THERAKOS
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO REPORTS OF A DEVICE MALFUNCTION HAVE BEEN RECEIVED TO DATE. A LOT FILE REVIEW WAS PERFORMED ON UVADEX LOT 1939641 (EXP: APR 2013). FORMULATION, FILLING, TERMINAL STERILIZATION, IN-PROCESS, AND FINAL QA TESTING ALL MET REQUIREMENTS. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, THERAKOS RECEIVED A REPORT OF A PT WHO DEVELOPED A RASH AND SWELLING AFTER RECEIVING THEIR 5 ECP TREATMENT ON (B)(6) 2011 AND RETURNED TO THE HOSPITAL FOR OBSERVATION. THE PT SEZARY SYNDROME AND EXTENSIVE PATCH PLAQUE CTCL. PREVIOUSLY TREATED WITH MTX (NO EFFICACY) AND TARGRETIN (DIFFUSE RASH WITH MILD DESQUAMATION). THE PT WAS TREATED WITH ECP 3 WEEKS AGO AND FIRST 2 TREATMENTS WERE WITHOUT EVENT. AFTER SECOND 2 TREATMENTS, THE PT DEVELOPED DIFFUSE ERYTHEMA, HIVES, FACIAL SWELLING WITHOUT BREATHING DIFFICULTIES AND WAS TREATED WITH ORAL STEROIDS ANTIHISTAMINES WITH RESOLUTION OVER THE INTERVENING WK. THE PT RECEIVED ECP TREATMENT #5 AND DEVELOPED DIFFUSE ERYTHEMA, ITCHING, HIVES, FACIAL SWELLING WITHOUT BREATHING DIFFICULTIES AFTER GOING HOME. THE PT WAS SEEN IN THE ECP UNIT ON THE MORNING OF (B)(6) 2011 AND WAS NOT IN ANY RESPIRATORY DISTRESS ALTHOUGH UNCOMFORTABLE FROM SKIN FINDINGS. THE PT WILL BE STARTED ON STEROIDS AND IS BEING EVALUATED BY THE ALLERGIST. ALTHOUGH THE REPORTER CONSIDERS THE EVENT SERIOUS, THEY DO NOT BELIEVE THE EVENT IS NECESSARILY RELATED AS THE PT DEVELOPED HIVES AND ALL AGAIN OVER A WEEK LATER. THE PT IS NO LONGER RECEIVING ECP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM XTS ECP SYSTEM LNR THERAKOS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other CLINDAMYCIN LOTION| BONIVA| KENALOG| HYDROXYZINE| ZANTAC| HYDROCODONE-HOMATROPINE| BENADRYL| CHLORAHEXADINE GLUCONATE| SARNA LOTION| CARMOL| ALBUTEROL| BENZONATATE| ELIDEL| NASONEX| CORDRAN| FLUOCINOLONE