BEUDAMED
    FDA Adverse Event Other Summary report: N

    SONICARE

    MDR report key: 2848319 · Received November 13, 2012

    Report

    Report Number
    3026630-2012-00019
    Event Type
    Other
    Date Received
    November 13, 2012
    Date of Event
    October 15, 2012
    Report Date
    November 13, 2012
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2012, CONSUMER STATED THAT THEIR DENTIST GAVE THE FOLLOWING DESCRIPTION: INCISAL FRACTURE OF THE ADAMANTINE ON TOOTH NUMBER 21. ON (B)(4) 2012 RECEIVED UNIT AND BROUGHT TO QUALITY LAB FOR EVAL. ON (B)(4) 2012 FAILURE ANALYSIS REPORT STATES THAT THE UNIT WAS RECEIVED IN GOOD CONDITION. BRUSH HEAD APPEARS NORMAL WITH WELL ROUNDED BRISTLE TIPS. SPECIFICATION TESTING WAS CONDUCTED AND BOTH HANDLE AND BRUSH HEAD MEET ALL SPECIFICATIONS. USING PROPER BRUSHING TECHNIQUE AS DESCRIBED IN THE DIRECTIONS FOR USE, WOULD NOT CREATE ENOUGH FORCE TO CRACK OR FRACTURE A SOUND TOOTH.

    Description of Event or Problem · 1

    ON (B)(6) 2012, CONSUMER STATED THEIR SONICARE FRACTURED THEIR TOOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONICARE HEALTHYWHITE JEQ PHILIPS ORAL HEALTHCARE HX6711

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other