BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS SONICARE

    MDR report key: 8842850 · Received July 30, 2019

    Report

    Report Number
    3026630-2019-00054
    Event Type
    Injury
    Date Received
    July 30, 2019
    Date of Event
    July 6, 2019
    Report Date
    July 30, 2019
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO INFORMATION PROVIDED. THE REPORTED SERIOUS INJURY WAS A DAMAGED DENTAL FILLING. THE EVENT DATE IS APPROXIMATE. THE BRUSH HEAD IS AN ACCESSORY TO THE ESSENCE POWER TOOTHBRUSH.

    Additional Manufacturer Narrative · 1

    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. IT IS NOT KNOWN HOW THE COUNTERFEIT PRODUCT WAS MANUFACTURED AND WHETHER OR NOT IT WAS REPROCESSED. THE ACTUAL DATE OF MANUFACTURE IS NOT KNOWN AT THIS TIME AS THE PRODUCT HAS BEEN IDENTIFIED AS COUNTERFEIT. THE PRODUCT WAS MARKETED TO THE CONSUMER AS A REUSABLE REPLACEMENT BRUSH HEAD. ANALYSIS RESULTS: FAILURE ANALYSIS OF THE RETURNED PRODUCT (PERFORMED AT PHILIPS ORAL HEALTHCARE) IDENTIFIED THAT A COUNTERFEIT BRUSH HEAD WAS THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT.

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT THE REPLACEMENT BRUSH HEAD FOR THEIR ESSENCE POWER TOOTHBRUSH BROKE THEIR DENTAL FILLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637622 PHILIPS SONICARE SONICARE BRUSH HEAD JEQ PHILIPS ORAL HEALTHCARE HX7012

    Patients

    Seq Age Sex Outcome Treatment
    1 Other