BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT

    MDR report key: 3823060 · Received January 17, 2014

    Report

    Report Number
    1419322-2013-00046
    Event Type
    Malfunction
    Date Received
    January 17, 2014
    Report Date
    December 20, 2013
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EKX
    PMA / PMN Number
    K031145
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE FDA PUBLIC HEALTH NOTIFICATION: PATIENT BURNS FROM ELECTRIC DENTAL HANDPIECES, ISSUED DECEMBER 12, 2007, "BURNS MAY NOT BE APPARENT TO THE OPERATOR OR THE PATIENT UNTIL AFTER THE TISSUE DAMAGE HAS BEEN DONE, BECAUSE THE ANESTHETIZED PATIENT CANNOT FEEL THE TISSUE BURNING AND THE HANDPIECE HOUSING INSULATES THE OPERATOR FROM THE HEATED ATTACHMENT." BECAUSE A SERIOUS INJURY OCCURED, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IN THIS EVENT A DOCTOR REPORTED THAT A PATIENT WAS BURNED ON THE LIP AFTER COMING INTO CONTACT WITH AN ESTYLUS 1:5 CA THAT ALLEGEDLY OVERHEATED. THE DENTIST REFERRED THE PATIENT TO A DERMATOLOGIST. THE DERMATOLOGIST DIAGNOSED IT AS A SECOND DEGREE BURN AND REFERRED THE PATIENT TO A PLASTIC SURGEON. IT IS UNKNOWN AS OF THIS MDR EVALUATION IF THE PATIENT HAS SEEN THE PLASTIC SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46094 ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT EKX DENTSPLY PROFESSIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention