BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS SONICARE

    MDR report key: 7715841 · Received July 24, 2018

    Report

    Report Number
    3026630-2018-00340
    Event Type
    Malfunction
    Date Received
    July 24, 2018
    Date of Event
    July 18, 2018
    Report Date
    July 18, 2018
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL TOOTHBRUSH HANDLE AND ACCESSORIES ANALYZED; NO MALFUNCTIONS OR ABNORMALITIES FOUND: PART NUMBER: DATE CODE: DESCRIPTION: HX9120, 170216, FLEXCARE PLATINUM CONNECTED (QTY: 2); HX6100, 170217 2B, TRITON BASE CHARGER (QTY: 2); HX904X, 170308 32M, ADAPTIVE CLEAN BRUSH HEAD (QTY: 2); HX903X, 170126 33M, PRORESULTS GUM HEALTH BRUSH HEAD (QTY: 2); HX900X, 170213 21M, INTERCARE BRUSH HEAD (QTY: 2). THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    CONSUMER CALLED STATING THAT THEIR SONICARE POWER TOOTHBRUSH CAUGHT FIRE. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557316 PHILIPS SONICARE FLEXCARE PLATINUM CONNECTED POWER TOOTHBRUSH JEQ PHILIPS ORAL HEALTHCARE HX9120

    Patients

    Seq Age Sex Outcome Treatment
    1