BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONICARE ESSENCE

    MDR report key: 1669336 · Received April 26, 2010

    Report

    Report Number
    3026630-2010-00003
    Event Type
    Injury
    Date Received
    April 26, 2010
    Date of Event
    February 24, 2010
    Report Date
    March 4, 2010
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STARTED USING THE TOOTH BRUSH AND THE HANDLE TURNED OFF. SO HE RESTED BRUSH HEAD ON HIS TONGUE TO TURN THE UNIT ON AGAIN WHEN HE TOOK THE UNIT OUT OF HIS MOUTH HE STARTED TO BLEED. THE BLEEDING LASTED ALL NIGHT AND THE NEXT MORNING. THE CUSTOMER WENT TO CLINIC AND WAS GIVEN 5 STITCHES AND THE TONGUE WAS CAUTERIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONICARE ESSENCE TOOTHBRUSH, POWERED JEQ PHILIPS ORAL HEALTHCARE HX5300 0926

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention