BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS SONICARE

    MDR report key: 7143854 · Received December 22, 2017

    Report

    Report Number
    3026630-2017-00377
    Event Type
    Injury
    Date Received
    December 22, 2017
    Date of Event
    December 11, 2017
    Report Date
    December 11, 2017
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CLARIFICATION: LOOSENING OF CROWN. THE SERIAL NUMBER WAS NOT PROVIDED AND THE UNIT HAS NOT BEEN RETURNED FOR EVALUATION. ONLY AN EMAIL ADDRESS WAS PROVIDED BY THE INITIAL REPORTER. THE MANUFACTURING DATE WAS NOT PROVIDED AND THE UNIT HAS NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CONSUMER STATES THAT THEIR CROWN HAS LOOSENED AFTER 2 WEEKS OF USING THEIR FLEXCARE POWER TOOTHBRUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922819 PHILIPS SONICARE FLEXCARE GREEN JEQ PHILIPS ORAL HEALTHCARE HX6970

    Patients

    Seq Age Sex Outcome Treatment
    1 Other