BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRALITE FULL BODY PHOTOTHERAPY UN

    MDR report key: 643112 · Received October 26, 2005

    Report

    Report Number
    1045025-2005-00001
    Event Type
    Other
    Date Received
    October 26, 2005
    Date of Event
    August 17, 2005
    Report Date
    October 17, 2005
    Manufacturer
    ULTRALITE ENTERPRISES, INC
    Product Code
    KGL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    LIGHT BULBS MALFUNCTIONED. PT GOING TO HOSP AS A PRECAUTION REGARDING BULB MALFUNCTION BUT NO PT INJURY. PT RECEIVED PAIN MEDS AND HAD ALREADY RESUMED TREATMENTS ON A DIFFERENT UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRALITE FULL BODY PHOTOTHERAPY UN ULTRALITE DERMATOLOGICAL LIGHT KGL ULTRALITE ENTERPRISES, INC V4848NB NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization