BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS SONICARE

    MDR report key: 7355873 · Received March 20, 2018

    Report

    Report Number
    3026630-2018-00295
    Event Type
    Injury
    Date Received
    March 20, 2018
    Date of Event
    February 16, 2018
    Report Date
    March 16, 2018
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER STATES THEY EXPERIENCED A BROKEN TOOTH/DENTAL IMPLANT. DATE OF EVENT IS APPROXIMATE. DEVICE MANUFACTURING DATE NOT AVAILABLE DUE TO THE TOOTHBRUSH HANDLE NOT BEING RETURNED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT RETURNED; EVALUATED AND NO ABNORMALITIES FOUND WITH THE EXCEPTION OF INTERCARE BRUSH HEAD WHICH HAD SLIGHT SCRATCHING ON THE BACK OF THE BRUSH HEAD, POSSIBLY FROM ABRASION WITH THE CUSTOMER TEETH OR IMPLANT. PART NUMBER: DATE CODE: DESCRIPTION: HX9100, 171009 1 DIAMOND, CLEAN BASE CHARGER. HX9210, 161114 1 DIAMOND, CLEAN TRAVEL CHARGER. HX904X, 171101 33M, ADAPTIVE CLEAN BRUSH HEAD. HX900X, 170914 21M, INTERCARE BRUSH HEAD. HX606X, 170904 11T, DIAMONDCLEAN BRUSH HEAD #1. HX606X, 171011 12T, DIAMONDCLEAN BRUSH HEAD #2. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    CONSUMER CALLED STATING THAT WHILE USING THE DIAMONDCLEAN TOOTHBRUSH IT JERKED BACK AND FORTH IN THEIR MOUTH CAUSING THEM TO BREAK A TOOTH IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196637 PHILIPS SONICARE DIAMONDCLEAN POWER TOOTHBRUSH JEQ PHILIPS ORAL HEALTHCARE HX939L

    Patients

    Seq Age Sex Outcome Treatment
    1 Other