BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRALITE HAND/FOOT 1200D

    MDR report key: 492097 · Received October 28, 2003

    Report

    Report Number
    1045025-2003-00001
    Event Type
    Injury
    Date Received
    October 28, 2003
    Date of Event
    April 1, 2003
    Report Date
    October 1, 2003
    Manufacturer
    ULTRALITE ENTERPRISES, INC.
    Product Code
    KGL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT CALLED OFFICE 2003 STATING THEY HAD BEEN BURNED ON BOTH FEET BY HF1200D. STATED THEY WERE IN THE HOSP 2 MONTHS. INSTITUTION DID TELL THE MFR THE UNIT WAS SERVICED BY AN OUTSIDE SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRALITE HAND/FOOT 1200D ULTRALITE DERMATOLOGICAL LIGHT KGL ULTRALITE ENTERPRISES, INC. HAND/FOOT 1200D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization