BEUDAMED
    FDA Adverse Event Other Summary report: N

    SONICARE

    MDR report key: 2824036 · Received October 26, 2012

    Report

    Report Number
    3026630-2012-00016
    Event Type
    Other
    Date Received
    October 26, 2012
    Date of Event
    September 27, 2012
    Report Date
    October 26, 2012
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012 A CALL WAS PLACED TO THE CONSUMER. CONSUMER STATES THAT HE HAD THE PRODUCT ABOUT 5 MONTHS. THE PRODUCT WAS REQUESTED TO BE SENT BACK FOR EVALUATION AND A REFUND WOULD BE PROCESSED. THE CONSUMER INDICATED THAT HE WANTS TO CONTINUE TO USE IT BECAUSE IT HELPED CORRECT SOME DENTAL PROBLEMS THAT HE HAD. CONSUMER INSISTS ON KEEPING THE BRUSH AND WILL NOT SEND BACK FOR EVALUATION. CONSUMER REQUESTED THAT REPLACEMENT BRUSH HEADS BE SENT TO HIM. BRUSH HEADS WERE SENT TO CONSUMER.

    Description of Event or Problem · 1

    ON (B)(6) 2012 CONSUMER STATES THAT WHILE USING THE TOOTHBRUSH HIS TOOTH CHIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONICARE DIAMONDCLEAN JEQ PHILIPS ORAL HEALTHCARE HX9340

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other