BEUDAMED
    FDA Adverse Event Other Summary report: N

    SONICARE

    MDR report key: 3592662 · Received January 8, 2014

    Report

    Report Number
    3026630-2013-00034
    Event Type
    Other
    Date Received
    January 8, 2014
    Date of Event
    December 19, 2013
    Report Date
    December 31, 2013
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013, CUSTOMER STATED THEY HAVE BEEN USING SONICARE TOOTHBRUSH FOR THREE WEEKS. CONSUMER STATED THAT DURING THE TIME OF USE THE CUSTOMER NOTICED THAT HIS TOOTH HAD BECOME SENSITIVE TO COLD AND THEN LATER, HE STARTED HAVING PAIN WHEN TRYING TO CHEW PRODUCTS. CUSTOMER ALSO STATED THAT HIS TOOTH BROKE IN HALF, BUT IT WAS NOT WHILE USING THE SONICARE TOOTHBRUSH. CUSTOMER DID HAVE TO GET A ROOT CANAL AND HAVE A CROWN PLACED ON TOOTH. CUSTOMER CLAIMS THAT THERE WERE ADVISED BY DENTIST TO CONTINUE USE OF THE SONICARE TOOTHBRUSH. CONSUMER STATES THAT THEIR DENTIST STILL STANDS BY THE PRODUCT AND BELIEVES IT IS A GOOD PRODUCT. CUSTOMER IS GOING TO CONTINUE USE OF THE SONICARE TOOTHBRUSH. CUSTOMER IS SEEKING COMPENSATION FOR DENTAL BILLS INCURRED WHILE USING THE SONICARE TOOTHBRUSH. CUSTOMER STATES THAT THEY WILL BE MAILING IN DENTAL BILLS TO SHOW CHARGES. 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 CLAIMS THAT HE HAD BEEN USING ORAL-B SPINBRUSH AND WAS TOLD BY DENTIST TO SWITCH TO SONICARE PRODUCT. CONSUMER STATES THAT AFTER SWITCHING TO SONICARE PRODUCT THEY STARTED EXPERIENCING DISCOMFORT IN TEETH. CUSTOMER ALSO STATED THAT HIS TOOTH BROKE IN HALF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14995 SONICARE EASYCLEAN JEQ PHILIPS ORAL HEALTHCARE HX6530

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other