BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS SONICARE

    MDR report key: 7128763 · Received December 19, 2017

    Report

    Report Number
    3026630-2017-00366
    Event Type
    Injury
    Date Received
    December 19, 2017
    Date of Event
    November 30, 2017
    Report Date
    November 30, 2017
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER STATED THEY EXPERIENCED A DENT IN ENAMEL OF TEETH. COMPLAINT RECEIVED FROM (B)(6).

    Description of Event or Problem · 1

    CONSUMER CALLED STATING THAT THEY NOTICED A DENT IN THE TWO FRONT TEETH AFTER USING THE 3-SERIES POWER TOOTHBRUSH. CONSUMER WENT TO DENTIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907293 PHILIPS SONICARE SONICARE TOOTHBRUSH JEQ PHILIPS ORAL HEALTHCARE HX6610 3-SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Other