BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS SONICARE

    MDR report key: 7355884 · Received March 20, 2018

    Report

    Report Number
    3026630-2018-00292
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Date of Event
    March 7, 2018
    Report Date
    March 7, 2018
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER PROVIDED IS FOR TOOTHBRUSH HANDLE. THE INCIDENT OCCURRED ON THE BRUSH HEAD WHICH IS AN ACCESSORY. THE SERIAL NUMBER OF THE BRUSH HEAD WAS NOT PROVIDED. DEVICE MANUFACTURING DATE NOT AVAILABLE DUE TO THE BRUSH HEAD NOT BEING RETURNED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCTS RETURNED AND EVALUATED; NO FAULT FOUND WITH THE ADDITIONAL HANDLE OR BRUSH HEADS PART NUMBER: DATE CODE: DESCRIPTION: HX681U 171102-2B PROTECTIVE CLEAN HANDLE (HANDLE #2); HX606X 171126 11T DIAMOND CLEAN BRUSH HEAD (BRUSH HEAD #1); HX606X 171126 11T DIAMOND CLEAN BRUSH HEAD (BRUSH HEAD #2). THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT IS A LOOSE COUPLER.

    Description of Event or Problem · 1

    CONSUMER CALLED STATING THAT THE BRUSH HEADS WILL NOT STAY ON THE TOOTHBRUSH HANDLE AND FELL OFF IN THEIR MOUTH. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196954 PHILIPS SONICARE DIAMOND CLEAN BRUSH HEAD (RFID) JEQ PHILIPS ORAL HEALTHCARE HX685J

    Patients

    Seq Age Sex Outcome Treatment
    1