BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDWEST TRADITION PB NON FIBER OPTIC

    MDR report key: 7149148 · Received December 27, 2017

    Report

    Report Number
    1419322-2017-00317
    Event Type
    Malfunction
    Date Received
    December 27, 2017
    Report Date
    December 27, 2017
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EFB
    PMA / PMN Number
    K963050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. THE DEVICE WAS EVALUATED AND FOUND TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IN THIS EVENT A DOCTOR REPORTED THAT A TRADITION HANDPIECE OVERHEATED. THERE WAS NO INJURY OR INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927427 MIDWEST TRADITION PB NON FIBER OPTIC HANDPIECE, AIR-POWERED, DENTAL EFB DENTSPLY PROFESSIONAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1