BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS SONICARE

    MDR report key: 7663443 · Received July 3, 2018

    Report

    Report Number
    MW5078236
    Event Type
    Injury
    Date Received
    July 3, 2018
    Date of Event
    June 18, 2018
    Report Date
    June 18, 2018
    Manufacturer
    PHILIPS ORAL HEALTHCARE INC.
    Product Code
    JEQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PLASTIC SHAFT PORTION OF MY NEW ELECTRIC TOOTHBRUSH BRUSH HEAD IS LEAVING MY LIPS FEELING ABRADED. I CANNOT FEEL A ROUGHNESS WITH MY FINGERS, BUT MY LIPS STING AND FEEL RAW WHERE THE SHAFT HAS RUBBED AGAINST THEM. TO BE CLEAR, IT'S NOT THE BRISTLES, BUT THE LONG STICK PART THAT HOLDS THE BRISTLES AND CONNECTS TO MY ELECTRIC TOOTHBRUSH. ADDITIONALLY, I WAS JUST HOLDING AND FINGERING THE BRUSH HEAD WHILE ON THE PHONE WITH PHILIPS (AN APPROX 15-MIN CALL) ABOUT THIS ISSUE, AND NOW MY FINGERS FEEL THAT ITCHY STING THAT IS UNIQUE TO EXPOSURE TO ABRASIVE MICRODUST SUCH AS FIBERGLASS. PHILIPS SONICARE COMPACT PRORESULTS. THIS IS THE FIRST BRUSH HEAD REMOVED FROM A JUST OPENED PACKAGE OF 3 BRUSH HEADS. UPC (B)(4). INCIDENT LOCATION: (B)(6), UNITED STATES; THIS IS MY HOME ADDRESS. PRODUCT DESCRIPTION: PHILIPS SONICARE COMPACT PRORESULTS BRUSH HEADS. NUMBERS ON PACKAGE INCLUDE UPC (B)(4). HX6023. (B)(4). THE BRUSH HEAD HAS A WHITE SHAFT WITH BLUE-GREEN BRISTLE WITH A SINGLE ROW OF BLUE BRISTLES. THE SHAFT OF THE BRUSH HEAD IS LABELED PHILIPS SONICARE (B)(4). THIS BRUSH HEAD FOR USE WITH A PHILIPS SONICARE ELECTRIC TOOTHBRUSH. DOCUMENT NUMBER: (B)(4). REPORT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499663 PHILIPS SONICARE TOOTHBRUSH POWERED JEQ PHILIPS ORAL HEALTHCARE INC. PHILIPS SONICARE PRORESULTS COMPACT HX6023

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR