BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS SONICARE

    MDR report key: 7512039 · Received May 14, 2018

    Report

    Report Number
    3026630-2018-00315
    Event Type
    Injury
    Date Received
    May 14, 2018
    Date of Event
    May 8, 2018
    Report Date
    May 8, 2018
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER STATES THEY EXPERIENCED THREE CHIPPED TEETH.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCTS RETURNED; EVALUATED WITH NO ABNORMALITIES DETECTED WITH THE EXCEPTION OF THE BRUSH HEAD, WHICH HAD SOME SCRATCHING AND DENTING ON THE BACK AS WELL AS THE FRONT, BACK, AND RIGHT SIDE OF THE BRUSH HEAD NECK, POSSIBLY FROM CONTACT WITH THE CUSTOMER'S TEETH. PART NUMBER: DATE CODE: DESCRIPTION: HX902X, 180214 21T, PRORESULTS PLAQUE CONTROL BRUSH HEAD (RFID). HX6100, 180124 2B TRITON, BASE CHARGER. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    CONSUMER CALLED STATING THAT THEY CHIPPED THREE TEETH WHILE USING THE PROTECTIVE CLEAN SONICARE TOOTHBRUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354945 PHILIPS SONICARE PROTECTIVE CLEAN POWER TOOTHBRUSH JEQ PHILIPS ORAL HEALTHCARE HX681A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other