BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 11025089 · Received December 17, 2020

    Report

    Report Number
    3026630-2020-00079
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    November 23, 2020
    Manufacturer
    PHILIPS ORAL HEALTHCARE, LLC
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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 CHARGER WAS IDENTIFIED AS THE ROOT CAUSE OF THE CONSUMER'S COMPLAINT. A2-A4: INFORMATION NOT PROVIDED. D1-D4: THE PRODUCT WAS SOLD TO THE CONSUMER BRANDED AS A PHILIPS SONICARE TOOTHBRUSH 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 SPECIFIC PRODUCT SYSTEM WAS NOT PROVIDED. THE PRODUCT MODEL #, CATALOG #, SERIAL # AND LOT # WERE NOT PROVIDED. THE SONICARE POWER TOOTHBRUSH CHARGER IS AN ACCESSORY TO THE SONICARE POWER TOOTHBRUSH SYSTEM. THE COMPLAINT WAS RECEIVED FROM A CONSUMER IN (B)(6). THE MANUFACTURE DATE CANNOT BE DETERMINED BASED ON THE PROVIDED INFORMATION.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THEIR SONICARE POWER TOOTHBRUSH CHARGER HAS FLAME CAME OUT AND CAUSED THE SAFETY FUSE TURN OFF. NO PROPERTY DAMAGE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497955 UNKNOWN UNKNOWN JEQ PHILIPS ORAL HEALTHCARE, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1