BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS SONICARE

    MDR report key: 10954427 · Received December 5, 2020

    Report

    Report Number
    3026630-2020-00078
    Event Type
    Injury
    Date Received
    December 5, 2020
    Date of Event
    November 5, 2020
    Manufacturer
    PHILIPS ORAL HEALTHCARE, LLC
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS RESULTS: FAILURE ANALYSIS OF THE RETURNED PRODUCT (PERFORMED AT PHILIPS ORAL HEALTHCARE) IDENTIFIED THAT A COUNTERFEIT BRUSH HEADS WERE IDENTIFIED AS THE ROOT CAUSE OF THE CONSUMER'S COMPLAINT. D1-D4: THE PRODUCT WAS SOLD TO THE CONSUMER BRANDED AS A PHILIPS SONICARE TOOTHBRUSH BRUSH HEAD HOWEVER THE PRODUCT WAS DETERMINED TO BE COUNTERFEIT. THEREFORE, NO INFORMATION IS CURRENTLY AVAILABLE DESCRIBING THE ACTUAL PRODUCT BRAND NAME, PRODUCT CODE, COMMON DEVICE NAME, MODEL NUMBER, SERIAL NUMBER, OR MANUFACTURER CONTACT INFORMATION. THE REPORTING MANUFACTURER IS PHILIPS ORAL HEALTHCARE. THE ACTUAL MANUFACTURER IS UNKNOWN. D8: IT IS NOT KNOWN HOW THE COUNTERFEIT PRODUCT WAS MANUFACTURED. G1: THE REPORTING MANUFACTURER IS PHILIPS ORAL HEALTHCARE. PHILIPS ORAL HEALTHCARE DID NOT MANUFACTURE THE PRODUCT THAT WAS RETURNED FOR ANALYSIS. H4: THE ACTUAL DATE OF MANUFACTURE IS NOT KNOWN AT THIS TIME AS THE PRODUCT HAS BEEN IDENTIFIED AS COUNTERFEIT.

    Additional Manufacturer Narrative · 1

    THE EVENT DATE IS APPROXIMATE. THE DIAMONDCLEAN BRUSH HEAD IS AN ACCESSORY TO THE DIAMONDCLEAN POWER TOOTHBRUSH SYSTEM. THE DEVICE SERIAL NUMBERS OR MANUFACTURING NUMBER WERE NOT PROVIDED. ANALYSIS RESULTS: THE ROOT CAUSE OF THE CUSTOMER¿S COMPLAINT WAS A BROKEN BRUSH HEAD.

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT THEIR DIAMONDCLEAN BRUSH HEADS BROKE OFF IN THEIR MOUTH DURING USE AND INJURIES GUM. A POTENTIAL CHOKING HAZARD WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1416837 PHILIPS SONICARE DIAMONDCLEAN BRUSH HEADS JEQ PHILIPS ORAL HEALTHCARE, LLC HX9332

    Patients

    Seq Age Sex Outcome Treatment
    1