BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS SONICARE

    MDR report key: 7268771 · Received February 13, 2018

    Report

    Report Number
    3026630-2018-00269
    Event Type
    Malfunction
    Date Received
    February 13, 2018
    Date of Event
    February 2, 2018
    Report Date
    February 2, 2018
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DIAMOND CLEAN BRUSH HEAD IS AN ACCESSORY TO THE SONICARE TOOTHBRUSH. THE MODEL NUMBER OF THE BRUSH HEAD WAS NOT PROVIDED. COMPLAINT RECEIVED FROM (B)(6). A RISK ASSESSMENT HAS BEEN PERFORMED INDICATING THE RISK OF SERIOUS INJURY FROM THIS MALFUNCTION IS UNLIKELY GIVEN ALL MATERIALS ARE BIOCOMPATIBLE AND THE BRISTLES ARE TOO SMALL TO BLOCK AIRWAY.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110098 PHILIPS SONICARE DIAMONDCLEAN BRUSH HEAD JEQ PHILIPS ORAL HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1