BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STYLUS MINI HIGH SPEED HANDPIECE

    MDR report key: 4250281 · Received November 6, 2014

    Report

    Report Number
    1419322-2014-00072
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Report Date
    October 7, 2014
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EFB
    PMA / PMN Number
    K003518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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 HAS BEEN A PREVIOUSLY REPORTED EVENT 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. EVALUATION FOUND THE CAP HAD DAMAGE TO THE RETAINING LEDGE.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT CAP UNSCREWED FROM A STYLUS MINI HANDPIECE WHILE IN USE. THE REPORTED COMPLAINT DID NOT RESULT IN AN INJURY OR NEED FOR INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714930 STYLUS MINI HIGH SPEED HANDPIECE AIR-POWERED DENTAL HANDPIECE EFB DENTSPLY PROFESSIONAL NA

    Patients

    Seq Age Sex Outcome Treatment
    1