BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS SONICARE

    MDR report key: 7434668 · Received April 16, 2018

    Report

    Report Number
    3026630-2018-00308
    Event Type
    Injury
    Date Received
    April 16, 2018
    Date of Event
    April 12, 2018
    Report Date
    April 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
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCTS RETURNED; EVALUATION INDICATES NO DEFECTS OR MALFUNCTIONS OTHER THAN TWO LONG FILAMENTS ON THE DIAMOND CLEAN BRUSH HEAD THAT WOULD NOT HAVE CAUSED THE REPORTED ISSUE: PART NUMBER: DATE CODE: DESCRIPTION: HX9100, 160723 2 DIAMOND, CLEAN BASE CHARGER. HX9210, 160712 2 DIAMOND, CLEAN TRAVEL CHARGER. HX605XX, 161214 3 SENSITIVE, BRUSH HEAD #1. HX605XX, 161214 3 SENSITIVE, BRUSH HEAD #2. HX606X, 160609 12T, DIAMONDCLEAN BRUSH HEAD. HX904X, 160220 32M 05,2 ADAPTIVE CLEAN BRUSH HEAD. HX900X 160906 22M 250 INTERCARE BRUSH HEAD THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    CONSUMER EXPERIENCED TWO BROKEN TEETH.

    Description of Event or Problem · 1

    CONSUMER CALLED STATING THAT THEY BROKE OFF TWO TEETH WHILE USING THEIR SONICARE POWER TOOTHBRUSH. NO MEDICAL ATTENTION WAS SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276911 PHILIPS SONICARE DIAMONDCLEAN POWER TOOTHBRUSH JEQ PHILIPS ORAL HEALTHCARE HX939W 160801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other