BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEMI

    MDR report key: 3830576 · Received May 23, 2014

    Report

    Report Number
    2024312-2014-00293
    Event Type
    Injury
    Date Received
    May 23, 2014
    Report Date
    April 29, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    EBZ
    PMA / PMN Number
    K071251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SPECIFICS WITH REGARD TO AGE AND WEIGHT WERE NOT PROVIDED BY THE DOCTOR. ALTHOUGH THE DOCTOR HAD IDENTIFIED TWO (2) DEMI LIGHTS ASSOCIATED WITH THE RED WELTS, SHE COULD NOT VERIFY WHICH SERIAL NUMBER WAS USED ON THE PATIENT. THE SERIAL NUMBERS OF THE LIGHTS INVOLVED IN THE ALLEGED INCIDENT INCLUDES SERIAL NUMBERS (B)(4). THE PATIENT HAD EXPERIENCED A RED WELT ON THE OUTSIDE OF HER MOUTH AFTER LIGHT CURING A BRACKET. THE DOCTOR PROVIDED NEOSPORIN AND MEDERMA TO THE PATIENT FOR TREATMENT. THE DOCTOR REPORTED THAT THE PATIENT WAS DOING FINE AT THIS TIME. THE PATIENT HAS SOME VERY SLIGHT HYPERPIGMENTATION AT THE SITE OF THE INJURY; HOWEVER, THE DOCTOR REPORTED THAT SHE HAS NO CONCERNS REGARDING THIS AND EXPECTS A FULL RECOVERY. THE DEVICE INVOLVED IN THE ALLEGED INCIDENT HAS NOT BEEN RETURNED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT THREE (3) PATIENTS HAD EXPERIENCED A RED WELT ON THE SIDE OF THEIR LIP AFTER THE DOCTOR HAD LIGHT CURED RESTORATIONS USING THE DEMI CURING LIGHT. THIS IS THE SECOND OF THREE (3) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308368 DEMI ACTIVATOR,ULTRAVIOLET,FORPOLYMERIZATION EBZ KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R