BEUDAMED
    FDA Adverse Event Other Summary report: N

    BELMONT-CLESTA-LIGHT

    MDR report key: 141805 · Received January 6, 1998

    Report

    Report Number
    MW1012749
    Event Type
    Other
    Date Received
    January 6, 1998
    Date of Event
    December 8, 1997
    Report Date
    December 19, 1997
    Manufacturer
    BELMONT EQUIPMENT CORP.
    Product Code
    EAZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE DENTAL APPOINTMENT OF 40 MIN DURATION, PT REPORTED EXPERIENCING HEAT, FLUSHING, ERYTHEMA TO FACE, CHEEKS, NOSE, THROAT; SYMPTOMS OF APPARANT SUNBURN. PT RULED OUT EFFECTS OF PREDNISONE 20 MG, AND NORVASC 5 MG. CONCLUSION: EXPOSURE TO TUNGSTEN-HALOGEN DENTAL LAMP. FDA'S 1992 ADVISORY TO MFRS AND IMPORTERS OF (DESK) LAMPS, WHICH NOTES THAT "WITHOUT PROPER ULTRAVIOLET RADIATION SHIELDING, EXPOSURE OF THE HANDS, FOREARMS OR FACES OF PERSONS CLOSE TO THE LAMPS MAY BE POSSIBLE AT LEVELS THAT MAY PRODUCE AN ERYTHEMAL (SUNBURN) RESPONSE IN A FEW HRS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BELMONT-CLESTA-LIGHT DENTAL LIGHT 24V 60W HALOGEN LAMP EAZ BELMONT EQUIPMENT CORP. 6014 *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other