BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT

    MDR report key: 1366812 · Received February 6, 2009

    Report

    Report Number
    1419322-2009-00005
    Event Type
    Malfunction
    Date Received
    February 6, 2009
    Date of Event
    January 7, 2009
    Report Date
    January 8, 2009
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EKX
    PMA / PMN Number
    K031145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE FDA PUBLIC HEALTH NOTIFICATION: PATIENT BURNS FROM ELECTRICAL DENTAL HANDPIECES, ISSUED DECEMBER 12, 2007, "BURNS MAY NOT BE APPARENT TO THE OPERATOR OR THE PATIENT UNTIL THE 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." THOUGH NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED IN THIS EVENT, THERE HAVE BEEN PREVIOUSLY REPORTED EVENTS RECEIVED IN THE LAST TWO YEARS INVOLVING THIS DEVICE THAT RESULTED IN THE NEED FOR MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE INVOLVED WAS RETURNED AND EVALUATED AND IT WAS FOUND THAT THE CAP WAS DAMAGED IN A MANNER CONSISTENT WITH THE HANDPIECE BEING DROPPED, CAUSING THE BUTTON TO STICK IN THE DOWNED POSITION, RESULTING IN FRICTION AND OVERHEATING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HANDPIECE BECAME HOT AND BURNED A PATIENT'S LIP. A BLISTER DEVELOPED AND THE PATIENT WAS ADMINISTERED IBUPROFEN AS A RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK