BEUDAMED
    FDA Adverse Event Other Summary report: N

    SONICARE

    MDR report key: 3592661 · Received January 8, 2014

    Report

    Report Number
    3026630-2013-00035
    Event Type
    Other
    Date Received
    January 8, 2014
    Date of Event
    December 25, 2013
    Report Date
    December 31, 2013
    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) 2013, REQUESTED THAT THE UNIT BE RETURNED FOR EVAL. ON (B)(4) 2013, REQUEST FOR DENTAL INFO IS RELATION TO THIS CLAIMED INCIDENT WAS SENT TO THE CONSUMER.

    Description of Event or Problem · 1

    ON (B)(6) /2013, CUSTOMER CLAIMS THAT AFTER STARTING USE WITH SONICARE TOOTHBRUSH 2 FILLINGS CAME OUT, AND CAUSED TWO TEETH TO BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14516 SONICARE EASYCLEAN JEQ PHILIPS ORAL HEALTHCARE HX6530

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other