BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHOTOTHERAPY CHAMBER

    MDR report key: 21918 · Received May 1, 1995

    Report

    Report Number
    21918
    Event Type
    Other
    Date Received
    May 1, 1995
    Date of Event
    April 24, 1995
    Report Date
    May 1, 1995
    Manufacturer
    ULTRALITE ENTERPRISES, INC.
    Product Code
    KGL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Description of Event or Problem · 1

    ULTRAVIOLET THERAPY CHAMBER WAS CLEANED BY A MAINTENANCE TECHNICIAN. ULTRAVIOLET A & B WAVE BULBS WERE REMOVED FOR CLEANING. WHEN BULBS WERE REPLACED THEY WERE NOT PUT IN THE CORRECT SLOTS THUS PTS WERE SUBJECTED TO INCORRECT PHOTOTHERAPY DOSAGES. FOUR PTS WERE GIVEN THERAPY BEFORE THE BULB MIXUP WAS DISCOVERED. THEY ALL RECEIVED 1ST DEGREE BURNS. THERE IS NO WARNING ON THE BULBS OR CHAMBER ADDRESSING THE POSSIBILITY OF BULB MIXUP. THERE ARE ONLY SMALL RED DOTS ABOVE THE RED SLOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOTOTHERAPY CHAMBER ULTRA VIOLET CHAMBER KGL ULTRALITE ENTERPRISES, INC. V4472-IV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other