BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT

    MDR report key: 3092408 · Received April 30, 2013

    Report

    Report Number
    1419322-2013-00009
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 2, 2013
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EKX
    PMA / PMN Number
    K031145
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE FDA PUBLIC HEALTH NOTIFICATION: PT BURNS FROM ELECTRIC DENTAL HANDPIECES, ISSUED 12/12/2007, "BURNS MAY NOT BE APPARENT TO THE OPERATOR OR THE PT UNTIL AFTER THE TISSUE DAMAGE HAS BEEN DONE, BECAUSE THE ANESTHETIZED PT CANNOT FEEL THE TISSUE BURNING AND THE HANDPIECE HOUSING INSULATES THE OPERATOR FROM THE HEATED ATTACHMENT." BECAUSE A SERIOUS INJURY OCCURRED, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR 803. THE 1:5 ESTYLUS ATTACHMENT EXCEEDED BOTH ISO13732-1 AND ES1104 TEMPERATURE LIMITATIONS AND FAILED TN8702 PERFORMANCE TESTING DUE TO THE CAP BEING LODGED IN THE DOWNWARD POSITION. THIS WAS DUE TO EXCESSIVE DEBRIS BUILDUP AND A FAILED CAP END BEARING RETAINER.

    Description of Event or Problem · 1

    IN THIS EVENT, A DOCTOR REPORTED THAT A PT WAS BURNED ON THE LIP AFTER COMING INTO CONTACT WITH A HANDPIECE HEAD THAT REPORTEDLY OVERHEATED. THE DOCTOR PRESCRIBED KENALOG 1% TO TREAT THE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188820 ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT EKX DENTSPLY PROFESSIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention