BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHILIPS SONICARE 2 SERIES

    MDR report key: 6069077 · Received October 31, 2016

    Report

    Report Number
    MW5065723
    Event Type
    Other
    Date Received
    October 31, 2016
    Date of Event
    April 11, 2016
    Report Date
    October 17, 2016
    Manufacturer
    PHILIPS
    Product Code
    JEQ
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PURCHASED A PHILIPS SONICARE 2 SERIES (MODEL HX 6211/04 TOOTHBRUSH FROM (B)(6) ON (B)(6) 2015. IT WAS REGISTERED WITH PHILIPS AND THE WARRANTY EXPIRED ON JUNE 1, 2018. I BROUGHT THE PRODUCT INTO USE FOR THE FIRST TIME IN (B)(6) 2016. EVEN AT THE FIRST USE, I NOTICED THAT THERE WAS EXCESSIVE VIBRATION OF THE TOOTHBRUSH, AND I REALLY COULD NOT PUT IT INTO MY MOUTH WITHOUT IT CHATTERING VIOLENTLY AGAINST MY TEETH, MAKING IT UNUSABLE. HOWEVER, WHEN I PRESSED THE TOOTHBRUSH TOWARDS THE HANDLE, THE VIBRATIONS WOULD BE CONTROLLED. BECAUSE OF THE EXCESSIVE VIBRATIONS, I AM UNABLE TO USE THE TOOTHBRUSH BECAUSE OF THE RISK OF DAMAGING MY TEETH OR GUMS, WHICH ARE SPECIALLY SENSITIVE AT MY AGE. I CALLED PHILIPS CUSTOMER CARE AT (B)(4) AND APPRISED THEM OF THE DEFECT. AT THEIR REQUEST, I SWITCHED ON THE BRUSH AND MADE THEM HEAR THE EXCESSIVE SOUNDS OF THE VIBRATING HEAD, AND ALSO THE REDUCED SOUND WHEN THE HEAD WAS PUSHED TOWARD THE HANDLE. THE AGENT AGREED THAT THERE WAS INDEED A DEFECT, AND THEY WOULD SEND ME A REPLACEMENT HANDLE. THE CASE NUMBER RELATED TO THIS CASE IS (B)(4). I WAS ALSO INFORMED BY SOME AGENTS THAT THIS PARTICULAR MODEL HAS HAD A NUMBER OF COMPLAINTS EARLIER TOO. THEREAFTER, UNTIL DATE, I HAVE BEEN IN CONTINUOUS CONTACT WITH PHILIPS CUSTOMER CARE AND THEIR CLAIMS SECTION. I HAVE BEEN SENT FOUR REPLACEMENT HANDLES, BUT THEY ALL HAVE THE VERY SAME DEFECT. I AM STILL SADDLED WITH THE SAME DEFECTIVE PRODUCT THAT I AM UNABLE TO USE BECAUSE OF THE RISK OF DAMAGING MY GUMS/TEETH. MAY I ASK YOU TO PLEASE LOOK INTO THIS CASE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719707 PHILIPS SONICARE 2 SERIES ELECTRIC TOOTHBRUSH JEQ PHILIPS HX6211/04
    719708 PHILIPS SONICARE 2 SERIES ELECTRIC TOOTHBRUSH JEQ PHILIPS HX6211/04
    719709 PHILIPS SONICARE 2 SERIES ELECTRIC TOOTHBRUSH JEQ PHILIPS HX6211/04
    719739 PHILIPS SONICARE 2 SERIES ELECTRIC TOOTHBRUSH JEQ PHILIPS HX6211/04

    Patients

    Seq Age Sex Outcome Treatment
    1