BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS SONICARE

    MDR report key: 19851959 · Received July 29, 2024

    Report

    Report Number
    3026630-2024-00064
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    July 19, 2024
    Report Date
    May 9, 2025
    Manufacturer
    PHILIPS ORAL HEALTHCARE, LLC
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT WAS NOT RETURNED TO CONFIRM A MALFUNCTION HAS OCCURRED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED NOR REQUIRED FOR INVESTIGATION. THE ROOT CAUSE HAS BEEN ADDRESSED AND EXECUTED THROUGH DESIGN CHANGE. THIS IS A KNOWN ISSUE WHICH HAS BEEN ADDRESSED BY PH OHC DESIGN CHANGE AND IMPLEMENTED.

    Description of Event or Problem · 0

    A CONSUMER REPORTED THAT THEIR PHILIPS ONE POWER TOOTHBRUSH CAUGHT FIRE WHILE CHARGING. NO INJURY OR PROPERTY DAMAGE WAS REPORTED.

    Description of Event or Problem · 0

    THE DEVICE WAS NOT RETURNED NOR REQUIRED FOR INVESTIGATION. THE ROOT CAUSE HAS BEEN ADDRESSED AND EXECUTED THROUGH DESIGN CHANGE. THIS IS A KNOWN ISSUE WHICH HAS BEEN ADDRESSED BY PH OHC DESIGN CHANGE AND IMPLEMENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384464 PHILIPS SONICARE PHILIPS ONE POWER TOOTHBRUSH JEQ PHILIPS ORAL HEALTHCARE, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown