BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS SONICARE

    MDR report key: 7211203 · Received January 22, 2018

    Report

    Report Number
    3026630-2018-00109
    Event Type
    Malfunction
    Date Received
    January 22, 2018
    Date of Event
    January 9, 2018
    Report Date
    January 9, 2018
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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.

    Description of Event or Problem · 1

    CONSUMER CALLED STATING THAT BRISTLES FROM THE SONICARE BRUSH HEAD WERE FALLING OFF IN THEIR MOUTH. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54662 PHILIPS SONICARE SONICARE BRUSH HEAD JEQ PHILIPS ORAL HEALTHCARE HX6930

    Patients

    Seq Age Sex Outcome Treatment
    1