BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS SONICARE

    MDR report key: 7671046 · Received July 9, 2018

    Report

    Report Number
    3026630-2018-00326
    Event Type
    Injury
    Date Received
    July 9, 2018
    Date of Event
    July 2, 2018
    Report Date
    July 2, 2018
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION NOT PROVIDED. INFORMATION NOT PROVIDED. CONSUMER EXPERIENCED LOST FILLINGS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL ACCESSORIES ANALYZED WITH NO MALFUNCTIONS OR ABNORMALITIES FOUND: PART NUMBER: DATE CODE: DESCRIPTION: HX90XX 171126 41M G3 PREMIUM GUM CARE STANDARD BRUSH HEAD; HX90XX 171025 42M C3 PREMIUM PLAQUE CONTROL BRUSH HEAD; CBA1001 3-170918 DIAMONDCLEAN SMART CHARGER BASE. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    CONSUMER CALLED STATING THAT HE LOST FIVE FILLINGS FROM THE VIBRATION OF THE DIAMONDCLEAN POWER TOOTHBRUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513262 PHILIPS SONICARE DIAMOND CLEAN SMART JEQ PHILIPS ORAL HEALTHCARE HX992W

    Patients

    Seq Age Sex Outcome Treatment
    1 Other