BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS SONICARE

    MDR report key: 7671054 · Received July 9, 2018

    Report

    Report Number
    3026630-2018-00327
    Event Type
    Injury
    Date Received
    July 9, 2018
    Date of Event
    July 1, 2018
    Report Date
    July 1, 2018
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER EXPERIENCED HURT GUMS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL ACCESSORY RECEIVED AND EVALUATED. PART NUMBER: DATE CODE: DESCRIPTION: HX606X, 150802 12T, DIAMONDCLEAN BRUSH HEAD (BRUSH HEAD #1). THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT IS A BROKEN BRUSH HUB AND LOOSE BRUSH HEAD COUPLER.

    Description of Event or Problem · 1

    CONSUMER CALLED STATING THAT THE BRUSH HEAD CAME OFF OF THE TOOTHBRUSH HANDLE WHILE BRUSHING AND THE METAL SHAFT HURT THEIR GUMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513265 PHILIPS SONICARE FLEX CARE POWER TOOTHBRUSH JEQ PHILIPS ORAL HEALTHCARE HX6932

    Patients

    Seq Age Sex Outcome Treatment
    1