BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHILIPS SONICARE

    MDR report key: 2615820 · Received June 8, 2012

    Report

    Report Number
    3026630-2012-00004
    Event Type
    Other
    Date Received
    June 8, 2012
    Date of Event
    May 8, 2012
    Report Date
    June 8, 2012
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER SUSTAINED AN INJURY (CUT INSIDE MOUTH) WHILE USING A SONICARE FOR KIDS POWERED TOOTHBRUSH. THE USER WAS "DANCING" WHILE BRUSHING AND ACCIDENTLY STRUCK THE TOOTHBRUSH WITH THEIR KNEE CAUSING THE INJURY. THE PRODUCT LABELING CLEARLY STATES IN SECTIONS DANGER AND WARNING. "THIS APPLIANCE IS NOT A TOY" AND "CHILDREN SHOULD BE SUPERVISED TO ENSURE THAT THEY DO NOT PLAY WITH THE APPLIANCE."

    Description of Event or Problem · 1

    ON (B)(6) 2012, CONSUMER STATES THAT HER DAUGHTER WAS BRUSHING HER TEETH AND DANCING AROUND. CONSUMER SAYS THAT HER DAUGHTER BROUGHT HER KNEE UP, WHICH KNOCKED HER ARM THAT SHE WAS HOLDING THE TOOTHBRUSH IN WHICH PUSHED THE TOOTHBRUSH UP INTO HER MOUTH CAUSING AN INCH DEEP CUT AND THE WIDTH OF THE BRUSH HEAD. CONSUMER EXPERIENCE MANAGER, HANDLING THE CASE, ASKED WHAT MEDICAL TREATMENT THE DAUGHTER RECEIVED. CONSUMER STATES THAT SHE WAS TAKEN TO THE WALK IN CENTRE IN (B)(6) WHO REFERRED HER TO THE DENTIST OFFICE, "(B)(6)."CONSUMER STATES THAT THE DENTAL OFFICE DID NOT DO ANYTHING BECAUSE THE CUT DID NOT REQUIRE STITCHES. CONSUMER STATES THAT THEIR PARTNER ALSO TOOK THE DAUGHTER TO THE HOSP (B)(6). CONSUMER CONCLUDES THAT "ALL [DOCTORS] HAVE CONFIRMED THAT IT [THE CUT] HAS HEALED FINE AND THAT THERE IS NO LASTING DAMAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS SONICARE SONICARE FOR KIDS JEQ PHILIPS ORAL HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other