BEUDAMED
    FDA Adverse Event Other Summary report: N

    SONICARE

    MDR report key: 3592680 · Received January 8, 2014

    Report

    Report Number
    3026630-2013-00029
    Event Type
    Other
    Date Received
    January 8, 2014
    Date of Event
    December 11, 2013
    Report Date
    December 31, 2013
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013 CALLED CUSTOMER AND NUMBER WAS NON WORKING. EMAIL WAS UNDELIVERABLE. SENT LETTER TO ADDRESS GIVEN REQUESTING A CALL BACK. 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 THE UNIT HAS CAUSED FIVE OF HER TEETH TO CHIP. SHE CLAIMS SHE HAS BEEN USING THE UNIT FOR TWO WEEKS AND NOW HAS TO GO THE DENTIST TO GET HER TEETH FIXED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14662 SONICARE FLEXCARE PLATINUM JEQ PHILIPS ORAL HEALTHCARE HX9140

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other