BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONICARE, DIAMONDCLEAN

    MDR report key: 6096342 · Received November 11, 2016

    Report

    Report Number
    3026630-2016-00019
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    August 18, 2016
    Report Date
    May 1, 2020
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CALLED NUMBER ON FILE. RECEIVED AUTOMATED MESSAGE "THE NUMBER YOU HAVE REACHED IS NOT IN SERVICE. PLEASE CHECK THE NUMBER AND TRY YOUR CALL AGAIN." NO EMAIL OR ADDRESS ON FILE. CONSUMER HUNG UP WHEN AGENT ASKED FOR CONTACT INFORMATION. THIS RECORD WAS ORIGINALLY SUBMITTED TO THE FDA ON (B)(6) 2016 BY (B)(6). PER THE FDA REQUEST FOR RESUBMISSION OF THE INITIAL REPORT ON (B)(6) 2020, THE RECORD WAS PREPARED FOR RESUBMISSION BASED ON OUR RECORDS OF THE ORIGINAL SUBMISSION. THE FOLLOWING FIELDS WERE REVISED TO ALIGN WITH THE DATE OF RESUBMISSION AND CURRENT ESUBMITTER VERSION. 'DATE OF THIS REPORT': REVISED FROM (B)(6) 2016 TO (B)(6) 2020. 'FAX NUMBER': REVISED FROM (B)(6) TO BLANK VALUE. 'REPROCESSOR NAME AND ADDRESS': REVISED FROM (B)(6) HEALTHCARE TO BLANK. VALUE. 'CONTACT OFFICE': REVISED FROM (B)(6). 'METHOD CODE(S)': REVISED FROM '3263-3323' TO '4114' TO ALIGN WITH CURRENT LIST OF CODES. 'CONCLUSION CODE(S)': REVISED FROM '67-92' TO '67' TO ALIGN WITH CURRENT LIST OF CODES. NO OTHER FIELDS WERE REVISED - ALL OTHER FIELDS ARE COPIED FROM THE ORIGINAL REPORT.

    Description of Event or Problem · 1

    CONSUMER CLAIMS "HAS A TOOTHBRUSH, DIAMOND CLEAN, PURCHASED 6 MONTHS AGO AND ADDED TOOTHBRUSH BRUSH HEADS WHICH HE OPENED UP THIS MORNING. WHILE HE WAS BRUSHING IT CRACKED AND CUT HIS MOUTH. HE DID NOT GO TO THE HOSPITAL. HE SAYS HIS MOUTH IS REALLY SORE AND HE CAN'T BRUSH HIS TEETH".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748921 SONICARE, DIAMONDCLEAN DIAMONDCLEAN JEQ PHILIPS ORAL HEALTHCARE HX6060

    Patients

    Seq Age Sex Outcome Treatment
    1 Male