BEUDAMED
    FDA Adverse Event Other Summary report: N

    SONICARE

    MDR report key: 3592686 · Received January 8, 2014

    Report

    Report Number
    3026630-2013-00037
    Event Type
    Other
    Date Received
    January 8, 2014
    Date of Event
    December 30, 2013
    Report Date
    December 31, 2013
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013, CUSTOMER STATES THAT THEY HAD RECEIVED THE TOOTBRUSH AS A GIFT ON (B)(6) 2013. CONSUMER STATES THAT THE CHIPPED TOOTH OCCURRED ON (B)(6) 2013. CUSTOMER STATED THAT THE LAST TIME SHE HAD SEEN A DENTIST WAS ON (B)(6) 2013. CUSTOMER STATED SHE WILL SEE THE DENTIST IN THE NEXT COMING WEEK TO SEE WHAT THEIR THOUGHTS ARE. REQUESTED THAT THE UNIT BE RETURNED FOR EVAL. ON (B)(4) 2013, REQUEST FOR DENTAL INFO IN RELATION TO THIS CLAIMED INCIDENT WAS SENT TO THE CONSUMER.

    Description of Event or Problem · 1

    ON (B)(6) 2013, CUSTOMER CLAIMED THAT AFTER USING THE ELITE TOOTHBRUSH THAT HER DAUGHTER NOTICED HER TOOTH HAD RECENTLY BEEN CHIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14663 SONICARE CLEANCARE/ESSENCE JEQ PHILIPS ORAL HEALTHCARE HX5910

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other