BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRALITE FULL BODY PHOTOTHERAPY UNIT

    MDR report key: 520342 · Received April 8, 2004

    Report

    Report Number
    1045025-2004-00001
    Event Type
    Injury
    Date Received
    April 8, 2004
    Date of Event
    January 21, 2003
    Report Date
    April 2, 2004
    Manufacturer
    ULTRALITE ENTERPRISES, INC.
    Product Code
    KGL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ULTRALITE ENTERPRISES, INC. BECAME AWARE OF AN EVENT THAT OCCURRED IN 1/2003, THROUGH CORRESPONDENCE FROM AN ATTORNEY. THE ATTORNEY STATES HIS CLIENT RECEIVED BURNS. AT A UNIVERSITY PHOTOTHERAPY DEPT. USING ULTRALITE EQUIPMENT. NO MODEL NUMBER, SERIAL NUMBER OR FURTHER INFO WAS GIVEN. IT WAS DECIDED THAT AN MDR SHOULD BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRALITE FULL BODY PHOTOTHERAPY UNIT UV DERMATOLOGY LIGHT KGL ULTRALITE ENTERPRISES, INC. NOT REPORTED NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R