BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STYLUS ATC

    MDR report key: 4231573 · Received October 18, 2014

    Report

    Report Number
    1419322-2014-00066
    Event Type
    Malfunction
    Date Received
    October 18, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 18, 2014
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EFB
    PMA / PMN Number
    K003518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED TO PRECLUDE A SERIOUS INJURY IN THIS EVENT, THERE HAVE BEEN PREVIOUSLY REPORTED EVENTS INVOLVING A SIMILAR 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. DENTSPLY WAS ABLE TO VERIFY THE COMPLAINT. ROOT CAUSE: CARTRIDGE, MAINTENANCE/DEBRIS.

    Description of Event or Problem · 1

    IN THIS EVENT A DOCTOR REPORTED THAT A SYTLUS ATC MINI HANDPIECE OVERHEATED AND BURNT A PATIENTS TONGUE. THE DOCTOR ADMINISTERED AN OVER THE COUNTER TOPICAL OINTMENT TO TREAT THE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663746 STYLUS ATC AIR-POWERED DENTAL HANDPIECE EFB DENTSPLY PROFESSIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1