BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLTOLUX LED 100/115V

    MDR report key: 12641123 · Received October 15, 2021

    Report

    Report Number
    2416455-2021-00006
    Event Type
    Malfunction
    Date Received
    October 15, 2021
    Date of Event
    September 16, 2021
    Report Date
    October 14, 2021
    Manufacturer
    COLTENE WHALEDENT INC.
    Product Code
    EBZ
    PMA / PMN Number
    K040551
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNIT WAS INSPECTED AND TESTED GOOD PER COLTENE PERFORMANCE TEST SPECIFICATION. WITH A TEMPERATURE PROBE IN DIRECT CONTACT WITH THE LIGHT LENS A TEMPERATURE OF 119.5°F WAS MEASURED DURING A 20 SECOND CURING CYCLE. THIS COMPARES WITH OTHER NEW CURING LIGHTS THAT WERE TESTED. THE MINIMUM TIME NEEDED FOR A FIRST DEGREE BURN IS 1 MINUTE AT 122°F, 5 SECONDS AT 131°F AND 2 SECONDS AT 140°F PER A TEMPERATURE/TIME/BURN CHART PUBLISHED BY JOHNS HOPKINS UNIVERSITY. THIS INDICATES THAT THE OFFICE MAY NOT HAVE BEEN FOLLOWING THE INSTRUCTIONS FOR USE IN THE OWNER'S GUIDE THAT STATE IF THE EXPOSURE TIME EXCEEDS 20 SECONDS COLTENE RECOMMENDS INCLUDING A COOLDOWN TIME BEFORE INITIATING ANOTHER CYCLE. FAILURE TO DO SO INCREASES THE RISK OF TISSUE BURNS AND INADVERTENT HEATING OF THE DENTAL PULP. NOTE TWO CONTINUOUS CYCLES RAN ON THE CUSTOMER'S UNIT WHICH IS NOT RECOMMENDED HAD A MAXIMUM TEMPERATURE OF 132.3°F WHICH COULD PRODUCE A 1ST DEGREE BURN IN 1 TO 2 SECONDS OF THE SECOND CYCLE.

    Description of Event or Problem · 1

    THE DOCTOR WAS PERFORMING FILLINGS WHEN ON THREE DIFFERENT OCCASIONS WITH THREE DIFFERENT PATIENTS THIS CURING LIGHT WAS CAUSING A BURN IN THEIR MOUTH. THE BURNS WERE ON THEIR GUMS AND LIP, NOT SPECIFYING WHERE. ONE OF THE PATIENTS WAS A (B)(6) GIRL, ANOTHER A (B)(6) FEMALE AND THE LAST SHE DID NOT REMEMBER. SHE SAID THAT THE PATIENTS RESOLVED THE BURN ON THEIR OWN NOT SAYING WHAT THEY DID TO TREAT IT. NO MEDICAL ATTENTION REQUIRED. THIS IS THE TYPE OF CURING LIGHT THEY ALWAYS USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536484 COLTOLUX LED 100/115V CURING LIGHT EBZ COLTENE WHALEDENT INC. +D661C79701001151

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Female Other