BEUDAMED
    FDA Adverse Event Other Summary report: N

    SONICARE

    MDR report key: 2818445 · Received October 17, 2012

    Report

    Report Number
    3026630-2012-00015
    Event Type
    Other
    Date Received
    October 17, 2012
    Date of Event
    September 17, 2012
    Report Date
    October 16, 2012
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012, A CALL WAS PLACED TO THE CONSUMER, HOWEVER, BLOCKED NUMBERS ARE NOT ACCEPTED. ON (B)(4) 2012, A CALL WAS PLACED TO THE CONSUMER USING THE COMPANY PHONE AND A MESSAGE WAS LEFT FOR A CALL BACK. ON (B)(4) 2012, SPOKE WITH CONSUMER. CONSUMER STATES THAT SHE HAS SPENT A GREAT DEAL OF MONEY ON CROWNS TO HAVE A NICE SMILE AND HER DENTIST RECOMMENDED THAT SHE USE A SONICARE. CONSUMER STATES THAT THIS WAS HER FIRST TIME USING THE UNIT. CONSUMER CLAIMS THAT IT WAS JUST A SMALL CHIP. CONSUMER ALSO STATED THAT SHE CAN CHEW, BUT THE CROWN WILL CONTINUE TO BREAK. REQUESTED THAT THE UNIT BE SENT IN FOR EVALUATION. A RETURN LABEL WAS SENT TO THE CONSUMER FOR SHIPPING OF THE DEVICE. ON (B)(4) 2012, A MESSAGE WAS LEFT TO CLARIFY WHETHER A TOOTH WAS CHIPPED OR A CROWN WAS CHIPPED. HAVE NOT RECEIVED THE UNIT, WILL FILE A FOLLOW UP.

    Description of Event or Problem · 1

    ON (B)(6) 2012, CONSUMER STATES THAT WHILE USING THE TOOTHBRUSH, A SMALL PIECE OF TOOTH CHIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONICARE FLEXCARE JEQ PHILIPS ORAL HEALTHCARE HX6910

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other