BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS SONICARE

    MDR report key: 7098274 · Received December 7, 2017

    Report

    Report Number
    3026630-2017-00307
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    November 1, 2017
    Report Date
    December 7, 2017
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    BRUSH HEADS RETURNED ALONG WITH TOOTHBRUSH HANDLE. HX900X, 170105 22M, INTERCARE BRUSH HEAD (BRUSH HEAD #1). HX903X, 170425 22M, PRORESULTS GUM HEALTH BRUSH HEAD (BRUSH HEAD #2). HX807X, 170*06 22T, TONGUE CARE (DATE CODE IS PARTIALLY ILLEGIBLE). THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINED ABOUT TOOTHBRUSH CHIPPING HIS TOOTH. CONSUMER WAS UNAWARE OF CHIPPED TOOTH UNTIL INFORMED BY DENTIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875883 PHILIPS SONICARE SONICARE FLEXCARE PLATINUM POWER TOOTH BRUSH JEQ PHILIPS ORAL HEALTHCARE HX9120

    Patients

    Seq Age Sex Outcome Treatment
    1 Other