BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS SONICARE

    MDR report key: 8547634 · Received April 24, 2019

    Report

    Report Number
    3026630-2019-00031
    Event Type
    Malfunction
    Date Received
    April 24, 2019
    Date of Event
    April 4, 2019
    Report Date
    June 25, 2019
    Manufacturer
    PHILIPS ORAL HEALTHCARE, LLC
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION/COUNTERFEIT INVESTIGATION: A COUNTERFEIT BRUSHEAD WAS IDENTIFIED AS THE ROOT CAUSE OF THE CONSUMER'S COMPLAINT AFTER EVALUATION OF THE RETURNED DEVICE. THE CONSUMER PURCHASED THE PRODUCT ON (B)(6). (B)(6) HAS BEEN CONTACTED BY PHILIPS TO HELP IDENTIFY THE MANUFACTURER OR THE THIRD PARTY SELLER THAT PERFORMED THE SALE FULFILLMENT. NO RESPONSE OR UPDATE HAS BEEN RECEIVED. PHILIPS INSPECTED THE PACKAGING THAT WAS RETURNED WITH THE COUNTERFEIT BRUSH HEAD AND COULD NOT IDENTIFY THE TRUE MANUFACTURER. BRAND NAME CORRECTED- THE INITIAL REPORT LISTED 'PHILIPS SONICARE' AS THE BRAND NAME. THIS IS INCORRECT. THE REPORTING MANUFACTURER BRAND NAME IS 'PHILIPS SONICARE' BUT THE TRUE MANUFACTURER OF THE COUNTERFEIT BRUSH HEAD IS NOT KNOWN. PROCODE: CORRECTED- THE INITIAL REPORT LISTED 'JEQ' AS THE PRODUCT CODE AND 'DIAMONDCLEAN POWER TOOTHBRUSH' AS THE COMMON DEVICE NAME. THIS IS INCORRECT. THE RETURNED PRODUCT WAS IDENTIFIED AS COUNTERFEIT. THEREFORE, THE TRUE PRODUCT CODE, COMMON DEVICE NAME, AND CORRESPONDING MODEL NUMBER IS NOT KNOWN. MANUFACTURER: CORRECTED- THE INITIAL REPORT LISTED' PHILIPS ORAL HEALTHCARE, LLC' AS THE MANUFACTURER. THIS IS INCORRECT. THE CONTACT INFORMATION AND ADDRESS OF THE MANUFACTURER OF THE COUNTERFEIT PRODUCT IS NOT KNOWN. THE INITIAL REPORT LISTED 'HX9332/10' AS THE MODEL NUMBER. THIS IS INCORRECT. THE MODEL NUMBER OF THE COUNTERFEIT PRODUCT IS NOT KNOWN. THE INITIAL REPORT LISTED 'NO' FOR WHETHER OR NOT THE PRODUCT WAS REPROCESSED FOR USE BASED OFF OF THE INITIALLY REPORTED INFORMATION THAT THE BRUSH HEAD WAS A PHILIPS SONICARE PRODUCT. THIS IS INCORRECT. IT IS NOT KNOWN HOW THE COUNTERFEIT PRODUCT WAS MANUFACTURED. ALL THE INFORMATION PROVIDED IN THE INITIAL REPORT ARE STILL ACCURATE FOR PHILIPS ORAL HEALTHCARE PRODUCTS. NONE OF THE INFORMATION APPLIES TO THE BRUSH HEAD THAT WAS RETURNED FOR ANALYSIS AS IT WAS NOT MANUFACTURED BY PHILIPS ORAL HEALTHCARE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION HAS IDENTIFIED THAT "PHILIPS SONICARE SUPPLY" IS THE (B)(6) SELLER THAT SOLD THE COUNTERFEIT PRODUCT TO THE CONSUMER. THIS COMPANY IS NOT A LEGITIMATE PHILIPS ORAL HEALTHCARE SUPPLIER. THE (B)(6) PRODUCT DESCRIPTION ALSO INCLUDED "(B)(6)" IN THE NAME. THE MANUFACTURER OF THE COUNTERFEIT IS STILL UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    CONSUMER STATED THAT THEIR TOOTHBRUSH HEAD SNAPPED OFF UNEXPECTEDLY LEADING TO ACCIDENTAL STABBING OF THEIR CHIN. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340461 PHILIPS SONICARE DIAMONDCLEAN POWER TOOTHBRUSH JEQ PHILIPS ORAL HEALTHCARE, LLC HX9332/10

    Patients

    Seq Age Sex Outcome Treatment
    1