BEUDAMED
    FDA Adverse Event Other Summary report: N

    SONICARE

    MDR report key: 2900275 · Received December 26, 2012

    Report

    Report Number
    3026630-2012-00022
    Event Type
    Other
    Date Received
    December 26, 2012
    Date of Event
    November 28, 2012
    Report Date
    December 24, 2012
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2012 - CONSUMER STATED IT WAS TOOTH #8 THAT THE UNIT CHIPPED. CONSUMER STATED THAT SHE THINKS IT (SONICARE) DID IT. CONSUMER STATES THAT SHE NOTICED THE CHIP AN HOUR AFTER SHE BRUSHED HER TEETH. CONSUMER STATED THAT SHE ATE A SOFT/CHEWY GRANOLA BAR AND IT MADE A DENT INTO THE FRONT OF HER TOOTH. CONSUMER STATED THAT SHE DID NOT SEEK ANY MEDICAL ATTENTION. CONSUMER STATED THAT SHE HAD THE UNIT FOR 2 WEEKS. A RETURN LABEL WAS SENT TO THE CONSUMER FOR SHIPPING OF THE DEVICE. (B)(4) 2012 - HAVE NOT RECEIVED THE UNIT, WILL FILE A FOLLOW UP.

    Description of Event or Problem · 1

    ON (B)(6) 2012 - CONSUMER STATES THAT THE UNIT CHIPPED HER TOOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONICARE FLEXCARE JEQ PHILIPS ORAL HEALTHCARE HX6930

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other