BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 14146156 · Received April 19, 2022

    Report

    Report Number
    3026630-2022-00042
    Event Type
    Malfunction
    Date Received
    April 19, 2022
    Date of Event
    April 6, 2022
    Manufacturer
    PHILIPS ORAL HEALTHCARE, LLC
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DATE IS APPROXIMATE. THE DEVICE SERIAL NUMBER OR MANUFACTURING NUMBER WERE NOT PROVIDED. THE COMPLAINT WAS RECEIVED FROM A CONSUMER IN (B)(6). MANUFACTURE DATE NOT PROVIDED OR IDENTIFIABLE.

    Additional Manufacturer Narrative · 0

    D1-D4: THE PRODUCT WAS RETURNED TO PHILIPS ORAL HEALTHCARE AT BOTHELL AND FAILURE ANALYSIS WAS PERFORMED AND DETERMINED NOT TO BE AN 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. 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. ANALYSIS RESULTS: ON 5/12/2022, THE RETURNED PRODUCT WAS PERFORMED AT PHILIPS ORAL HEALTHCARE LAB AND FAILURE ANALYSIS IDENTIFIED THAT BRUSH HEAD 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 THEIR ADAPTIVE CLEAN BRUSHHEAD SNAPPED INSIDE MOUTH DURING USE. NO INJURIES WERE REPORTED. A POTENTIAL CHOKING HAZARD WAS IDENTIFIED.

    Description of Event or Problem · 0

    A CONSUMER REPORTED THEIR ADAPTIVE CLEAN BRUSH HEAD SNAPPED INSIDE MOUTH DURING USE. NO INJURIES WERE REPORTED. 05/12/2022. THE PRODUCT WAS RETURNED TO PHILIPS ORAL HEALTHCARE AT BOTHELL AND FAILURE ANALYSIS WAS PERFORMED AND IDENTIFIED THAT BRUSH HEAD WAS NOT AUTHENTIC PHILIPS PRODUCT AS THE CAUSE OF THE CONSUMER'S COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818968 UNKNOWN UNKNOWN JEQ PHILIPS ORAL HEALTHCARE, LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown