BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS SONICARE

    MDR report key: 7390499 · Received April 2, 2018

    Report

    Report Number
    3026630-2018-00301
    Event Type
    Injury
    Date Received
    April 2, 2018
    Date of Event
    March 29, 2018
    Report Date
    March 29, 2018
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCTS/COMPONENTS RETURNED; NO MALFUNCTION OR DEFICIENCIES FOUND UPON EVALUATION: PART NUMBER: DATE CODE: DESCRIPTION: HX682P, 171129-2B PROTECTIVE, CLEAN HANDLE (HANDLE #1). HX682P, 171124-3B PROTECTIVE, CLEAN HANDLE (HANDLE #2). HX903X, 171224 23T, PRORESULTS GUM HEALTH BRUSH HEAD RFID (BRUSH HEAD #2). HX903X, 171224 23T, PRORESULTS GUM HEALTH BRUSH HEAD RFID (BRUSH HEAD #3) .HX6100, 1711132B TRITON BASE, CHARGER (CHARGER #1). HX6100, 1711132B TRITON BASE, CHARGER (CHARGER #2). THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT IS A LOOSE BRUSH HEAD COUPLER

    Additional Manufacturer Narrative · 1

    CONSUMER STATED THEY EXPERIENCED A BROKEN TOOTH. THE SERIAL NUMBER OF THE TOOTHBRUSH WAS NOT PROVIDED. DEVICE MANUFACTURING DATE NOT AVAILABLE DUE TO THE TOOTHBRUSH NOT BEING RETURNED.

    Description of Event or Problem · 1

    CONSUMER CALLED STATING THAT THE BRUSH HEAD CAME OFF OF THE TOOTHBRUSH HANDLE WHILE BRUSHING THEIR TEETH AND BROKE THEIR TOOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230780 PHILIPS SONICARE DIAMOND CLEAN BRUSH HEAD RFID JEQ PHILIPS ORAL HEALTHCARE HX606X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other