BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS SONICARE

    MDR report key: 7130552 · Received December 19, 2017

    Report

    Report Number
    3026630-2017-00363
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    December 2, 2017
    Report Date
    December 2, 2017
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DIAMONDCLEAN BRUSH HEAD IS AN ACCESSORY TO THE SONICARE TOOTHBRUSH. THE SERIAL NUMBER OF THE BRUSH HEAD WAS NOT PROVIDED. DEVICE MANUFACTURING DATE NOT AVAILABLE DUE TO THE BRUSH HEAD NOT BEING RETURNED.

    Description of Event or Problem · 1

    CONSUMER CALLED STATING THAT BRISTLES FROM THE DIAMONDCLEAN BRUSH HEAD WERE FALLING OUT IN THEIR MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909594 PHILIPS SONICARE DIAMONDCLEAN BRUSH HEAD JEQ PHILIPS ORAL HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1