BEUDAMED
    FDA Adverse Event Other Summary report: N

    SONICARE

    MDR report key: 2796866 · Received October 13, 2012

    Report

    Report Number
    3026630-2012-00014
    Event Type
    Other
    Date Received
    October 13, 2012
    Date of Event
    September 14, 2012
    Report Date
    October 13, 2012
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2012, CONSUMER STATES THAT SHE HAD BEEN USING THE PRODUCT FOR ABOUT 3 WEEKS AND A LITTLE PIECE OF HER TOOTH BECAME LOOSE AND FELL OFF. CONSUMER CLAIMS THAT SHE THINKS THE PIECE OF TOOTH FELL OFF BECAUSE HER TEETH ARE OLDER AND FRAGILE. CONSUMER STATES THAT THE DENTIST PUT A FILLING IN. CONSUMER WAS ISSUED A REFUND FOR THE PRODUCT. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION. (B)(4) 2012, UNIT RECEIVED FOR EVALUATION. (B)(4) 2012, FAILURE ANALYSIS COMPLETED. UNIT RECEIVED IN MODERATELY USED CONDITION. UPON MICROSCOPIC EXAMINATION, THE NOZZLE TIP APPEARS SMOOTH WITH ONLY MINOR IRREGULARITIES FROM NORMAL USAGE. UNIT PASSES FUNCTIONAL SPECIFICATIONS AND THE NOZZLE APPEARS NORMAL. ROOT CAUSE OF CUSTOMER COMPLAINT UNKNOWN.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONICARE AIRFLOSS JEQ PHILIPS ORAL HEALTHCARE HX8140

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other