BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONICARE

    MDR report key: 4987813 · Received August 5, 2015

    Report

    Report Number
    3026630-2015-00036
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    July 6, 2015
    Report Date
    August 5, 2015
    Manufacturer
    PHILIPS ORAL HEALTHCARE, INC.
    Product Code
    JEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015 CONSUMER STATED THEY DID NOT USE THE TOOTHBRUSH ON THEIR GUMS AGAIN, ALTHOUGH THEY DID ON A COUPLE OF OCCASIONS TRY TO USE IT AROUND THEIR TEETH (STICKING WITH THEIR USUAL TOOTHBRUSH THE REST OF THE TIME). CONSUMER STATED THAT THEY FELT IRRITATION OF THE AREA AFTER A FEW DAYS AND WENT TO THEIR DENTIST FOR AN EMERGENCY APPOINTMENT. CONSUMER STATED THAT THEY WERE GIVEN A COURSE OF AMOXICILLIN 500MG CAPSULES TO TREAT AN INFECTION ((B)(6) 2015). CONSUMER STATED THAT WITH LITTLE IMPROVEMENT THEY WERE THEN GIVEN A COURSE OF METRONIDAZOLE 400MG TABLETS ((B)(6) 2015). CONSUMER STATES THAT THEIR GUMS HAVE RECEDED AROUND 1MM IN SOME AREAS. CONSUMER RETURNED THE UNIT FOR EVALUATION, FAILURE ANALYSIS REPORT PENDING.

    Description of Event or Problem · 1

    ON (B)(6) 2015 CONSUMER CLAIMS THAT DESPITE USING THE TOOTHBRUSH ON THE LOWEST INTENSITY ON THE "GUMCARE" SETTING VERY GENTLY, ONLY ONE USE RESULTED IN THREE SMALL HOLES BEING RUBBED IN THE GUMS BELOW THEIR LOWER FRONT TEETH. CONSUMER STATES THAT THEY ARE CERTAIN THIS OCCURRED IN ONLY ONE USE AS THEY INSPECTED THEIR GUMS BOTH BEFORE AND AFTER USING THE BRUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515575 SONICARE FLEXCARE PLATINUM JEQ JEQ PHILIPS ORAL HEALTHCARE, INC. HX9140

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other