BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS SONICARE

    MDR report key: 7123537 · Received December 15, 2017

    Report

    Report Number
    3026630-2017-00360
    Event Type
    Injury
    Date Received
    December 15, 2017
    Date of Event
    November 22, 2017
    Report Date
    November 29, 2017
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DATE IS AN APPROXIMATION AS THE CUSTOMERS STATED ABOUT A WEEK AGO FROM AWARE DATE. MODEL NUMBER PROVIDED IS FOR TOOTHBRUSH HANDLE. THE INCIDENT OCCURRED ON THE SONICARE FOR KIDS 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 THE SONICARE FOR KIDS BRUSH HEAD HAD TWO (2) TUFTS OF BRISTLES FALL OUT IN THEIR CHILD'S MOUTH AND CAUSE A CHOKING SENSATION. THE BRISTLES WERE SPIT OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901479 PHILIPS SONICARE DIAMONDCLEAN BRUSH HEAD JEQ PHILIPS ORAL HEALTHCARE HX606X

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other