BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT

    MDR report key: 3143152 · Received May 31, 2013

    Report

    Report Number
    1419322-2013-00017
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    May 3, 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: PATIENT BURNS FORM ELECTRIC DENTAL HANDPIECE, ISSUED 12/12/2007, "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 OCCURRED, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE 1:5 ESTYLUS ATTACHMENT EXCEEDS (B)(4) FOR MAXIMUM ALLOWABLE TEMPERATURE. EVIDENCE WAS FOUND SUPPORTING THE COMPLAINT FOR "THE ATTACHMENT GOT VERY HOT AND BURNT A PATIENT" BECAUSE OF SET ASSEMBLY INSTABILITY DUE TO BOTH BEARING BEING FOUND DETACHED FROM THE SET, CONTACT FOUND BETWEEN THE PUSHER AND THE CAP ASSEMBLY DURING USE AND DAMAGE TO THE COLOR RING.

    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 HANDPIECE HEAD THAT REPORTEDLY OVERHEATED. THE DOCTOR PRESCRIBED A PRESCRIPTION MOUTHWASH TO TREAT THE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242024 ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT EKX DENTSPLY PROFESSIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention