BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLTOLUX CURING LIGHT

    MDR report key: 70416 · Received February 14, 1997

    Report

    Report Number
    2416455-1997-00001
    Event Type
    Malfunction
    Date Received
    February 14, 1997
    Date of Event
    February 4, 1997
    Report Date
    February 13, 1997
    Manufacturer
    COLTENE/WHALDENT INC.
    Product Code
    EAY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    RECEIVED A TELEPHONE CALL THAT REPORTED THAT THE LIGHT GUIDE OF A CURING LIGHT HAD "EXPLODED" IN THE PT'S MOUTH WHILE LIGHT CURING A RESTORATION. DUE TO THE FACT THAT THE DENTIST HAD PLACED RUBBER DAM, THERE WERE NO ADVERSE EFFECTS TO THE PT. THE LIGHT GUIDE IS ALL AN ACCESSORY DEVICE TO THE CURING LIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLTOLUX CURING LIGHT VISIBLE LIGHT CURING DENTAL MATERIAL EAY COLTENE/WHALDENT INC. C-7921 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other