BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLUS MINI HIGH SPEED HANDPIECE

    MDR report key: 3802845 · Received May 2, 2014

    Report

    Report Number
    1419322-2014-00020
    Event Type
    Injury
    Date Received
    May 2, 2014
    Report Date
    April 7, 2014
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EFB
    PMA / PMN Number
    K003518
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR PRESCRIBED A PRESCRIPTION OINTMENT TO TREAT THE BURN. UPON EVALUATION OF THE HANDPIECE, IT WAS DETERMINED THAT THE DENTAL OFFICE HAD REPLACED THE CARTRIDGE SET WITH AN AFTERMARKET, NON-DENTSPLY SPECIFIED CARTRIDGE SET. BECAUSE A SERIOUS INJURY OCCURRED, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE WAS EVALUATED AND FOUND TO HAVE A NON-DENTSPLY AFTERMARKET CARTRIDGE SET.

    Description of Event or Problem · 1

    IN THIS EVENT A DOCTOR REPORTED THAT A PATIENT WAS BURNED INSIDE THE MOUTH WHEN THEY CAME IN CONTACT WITH A STYLUS HANDPIECE THAT ALLEGEDLY OVERHEATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263742 STYLUS MINI HIGH SPEED HANDPIECE HANDPIECE, AIR-POWERED, DENTAL EFB DENTSPLY PROFESSIONAL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention