BEUDAMED
    FDA Adverse Event Other Summary report: N

    SONICARE

    MDR report key: 3592660 · Received January 8, 2014

    Report

    Report Number
    3026630-2013-00030
    Event Type
    Other
    Date Received
    January 8, 2014
    Date of Event
    December 12, 2013
    Report Date
    December 31, 2013
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013, SPOKE WITH THE CUSTOMER. CLAIMS THAT HER (B)(6) DAUGHTER WAS BRUSHING TOP MOLARS AND THE UNIT SLIPPED OFF HER TEETH AND CUT THE INSIDE OF THEIR MOUTH. CLAIMS THAT THEY HAD HER RINSE ABOUT FOUR TIMES WITH WATER TO CLEAN ALL THE BLOOD OUT OF HER MOUTH WHICH IS WHEN THEY NOTICED THE CUT. CLAIMS THAT THE DAUGHTER WAS TAKEN TO THE DENTIST WHO PUT TWO STITCHES IN HER MOUTH AND PUT HER ON ANTIBIOTICS. THEY HAVE HAD THE UNIT FOR ABOUT A YEAR AND HALF AND HAVE ONLY CHANGED THE BRUSH HEADS ONE TIME. ON (B)(4) 2013. CONSUMER AGREED TO RETURN THE PRODUCT FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2013, CUSTOMER CLAIMS THAT WHILE THEIR CHILD WAS BRUSHING THEIR TEETH, THE TOOTHBRUSH FLIPPED OUT OF HER MOUTH, WHICH SEVERELY CUT THE CHILD. THE CUSTOMER STATED THEY WENT TO THE DENTIST AND CHILD RECEIVED TWO STITCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14704 SONICARE SONICARE FOR KIDS JEQ PHILIPS ORAL HEALTHCARE HX6330

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other