BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 14062454 · Received April 8, 2022

    Report

    Report Number
    3026630-2022-00036
    Event Type
    Malfunction
    Date Received
    April 8, 2022
    Date of Event
    March 24, 2022
    Manufacturer
    PHILIPS ORAL HEALTHCARE, LLC
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DATE IS APPROXIMATE. THE ISSUE IS REPORTED TO BE WITH THE ACCESSORY CHARGER OF THE DIAMONDCLEAN POWER TOOTHBRUSH SYSTEM. THE COMPLAINT WAS RECEIVED FROM A CONSUMER IN (B)(6).

    Additional Manufacturer Narrative · 0

    D1-D4: THE PRODUCT WAS RETURNED TO PHILIPS ORAL HEALTHCARE AT BOTHELL AND FAILURE ANALYSIS WAS PERFORMED AND DETERMINED TO BE NON AUTHENTIC PHILIPS PRODUCT. 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. 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 NOT AUTHENTIC PHILIPS PRODUCT. H5: IT IS UNKNOWN HOW THE COUNTERFEIT PRODUCT LABELED FOR SINGLE USE OR NOT. ANALYSIS RESULTS: ON 06/14/2022, THE RETURNED PRODUCT WAS PERFORMED AT PHILIPS ORAL HEALTHCARE LAB AND FAILURE ANALYSIS IDENTIFIED THAT CHARGER WAS NOT AN AUTHENTIC PHILIPS PRODUCT AS THE CAUSE OF THE CONSUMER'S COMPLAINT. THEREFORE, THIS CASE WAS RE-REVIEWED AND DEEMED TO BE NOT REPORTABLE.

    Description of Event or Problem · 0

    A CONSUMER REPORTED THAT THEIR DIAMONDCLEAN POWER TOOTHBRUSH CHARGING GLASS EXPLODED. NO PROPERTY DAMAGE AND NO INJURY WERE REPORTED.

    Description of Event or Problem · 0

    A CONSUMER REPORTED THAT THEIR DIAMONDCLEAN POWER TOOTHBRUSH CHARGING GLASS EXPLODED. NO PROPERTY DAMAGE AND NO INJURY WERE REPORTED. 06/14/2022, THE RETURNED PRODUCT WAS PERFORMED AT PHILIPS ORAL HEALTHCARE LAB AND FAILURE ANALYSIS IDENTIFIED THAT CHARGER WAS NOT AN AUTHENTIC PHILIPS PRODUCT AS THE CAUSE OF THE CONSUMER'S COMPLAINT. THEREFORE, THIS CASE WAS RE-REVIEWED AND DEEMED TO BE NOT REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1187999 UNKNOWN CHARGER JEQ PHILIPS ORAL HEALTHCARE, LLC HX9100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown