BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS SONICARE

    MDR report key: 7371688 · Received March 26, 2018

    Report

    Report Number
    3026630-2018-00297
    Event Type
    Injury
    Date Received
    March 26, 2018
    Date of Event
    March 10, 2018
    Report Date
    March 12, 2018
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER EXPERIENCED CHIPPED AND LOOSE FILLINGS. REPORT SOURCE: COMPLAINT RECEIVED FROM THE (B)(6).

    Additional Manufacturer Narrative · 1

    ADDITIONAL ACCESSORIES RETURNED AND NO MALFUNCTIONS DETECTED: PART NUMBER: DATE CODE: DESCRIPTION: HX6100, 161130 2B, TRITON BASE CHARGER. HX903X, 160712 33M 194, PRORESULTS GUM HEALTH.

    Description of Event or Problem · 1

    CONSUMER CALLED STATING THAT THEY EXPERIENCED A CHIPPED FILLING FROM A MOLAR AND A LOOSE FILLING FROM AN INCISOR WHILE USING A SONICARE POWER TOOTHBRUSH. CONSUMER'S DENTIST STATED THAT THE FILLINGS MAY NOT HAVE BEEN STURDY ENOUGH AND MAY HAVE COME LOOSE LATER WITH A DIFFERENT TYPE OF ELECTRIC TOOTHBRUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211968 PHILIPS SONICARE ESSENCE+ POWER TOOTHBRUSH JEQ PHILIPS ORAL HEALTHCARE HX3220A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other