BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS SONICARE

    MDR report key: 7705206 · Received July 19, 2018

    Report

    Report Number
    3026630-2018-00333
    Event Type
    Injury
    Date Received
    July 19, 2018
    Date of Event
    July 6, 2018
    Report Date
    July 6, 2018
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER STATED THEY EXPERIENCED ENAMEL DEFECTS. THE SERIAL NUMBER OF THE TOOTHBRUSH WAS NOT PROVIDED. COMPLAINT RECEIVED FROM (B)(4). DEVICE MANUFACTURING DATE NOT AVAILABLE DUE TO THE TOOTHBRUSH NOT BEING RETURNED.

    Additional Manufacturer Narrative · 1

    ADDITONAL ACCESSORIES RETURNED AND NO MALFUNCTION FOUND UPON ANALYSIS: PART NUMBER: DATE CODE: DESCRIPTION: HX9100 151216 2 DIAMONDCLEAN BASE CHARGER; HX9210 160601 3 TRAVEL CASE CHARGER; HX606X 160610 11M 163 BLACK DIAMONDCLEAN BRUSH HEAD; HX900X 160610 22M 162 INTERCARE BRUSH HEAD. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    CONSUMER CALLED STATING THAT THEY EXPERIENCED ENAMEL DEFECTS AT THE JUNCTION OF THEIR TEETH AND GUMS WHILE USING A SONICARE POWER TOOTHBRUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544102 PHILIPS SONICARE BLACK DIAMONDCLEAN REFRESH JEQ PHILIPS ORAL HEALTHCARE HX939B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other