BEUDAMED
    FDA Adverse Event Other Summary report: N

    SONICARE HEALTHY WHITE

    MDR report key: 1357973 · Received April 6, 2009

    Report

    Report Number
    3026630-2009-00001
    Event Type
    Other
    Date Received
    April 6, 2009
    Date of Event
    March 8, 2009
    Report Date
    March 16, 2009
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    PMA / PMN Number
    K040416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DIGITAL PHOTOGRAPHS PROVIDED BY CONSUMER WERE REVIEWED BY THE TOOLING MANAGER AND THE SUPPLIER QUALITY ENGINEER. THESE WERE COMPARED TO INTERNAL COMPONENTS. OTHER INFORMATION: HEALTHY WHITE POWERED TOOTHBRUSH WAS USED TWICE. THE FAILURE MODE WAS NOTED TO BE CAUSED BY UNUSUAL EXCESSIVE PRESSURE OPPOSITE TO NORMAL METHOD OF USE. THE CUSTOMER WAS NOT CLEAR IN THEIR ACTIONS AT THE TIME OF THE INCIDENT, BUT IT WAS COMMUNICATED THEY WERE NOT IN THE BATHROOM.

    Description of Event or Problem · 1

    CUSTOMER REPORTED BRUSH HEAD SNAPPED OFF IN HIS MOUTH WHILE HE WAS BRUSHING HIS BACK MOLARS. HE SUBSEQUENTLY GOT THE BRUSH HEAD LODGED IN HIS THROAT. HE WAS ABLE TO WORK IT UP IN HIS THROAT, USING COUGHING AND GAGING REFLEXES, TO A POSITION WHERE HE COULD PULL IT OUT WITH HIS FINGERS. THE CUSTOMER WAS TAKEN TO THE HOSPITAL FOR AN XRAY AND INSTRUCTED TO HAVE CLOSE SUPERVISION AT HOME THAT EVENING AND TO WATCH FOR THROAT SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONICARE HEALTHY WHITE TOOTHBRUSH, POWERED JEQ PHILIPS ORAL HEALTHCARE HX6711

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other