BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONICARE

    MDR report key: 4987823 · Received August 5, 2015

    Report

    Report Number
    3026630-2015-00033
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    July 8, 2015
    Report Date
    August 5, 2015
    Manufacturer
    PHILIPS ORAL HEALTHCARE, INC.
    Product Code
    JEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER HAS NOT RESPONDED TO CONTACT ATTEMPTS. ON (B)(6) 2015, CONSUMER STATED THAT THE BRUSH HEAD WAS NO LONGER AVAILABLE TO BE RETURNED. CONSUMER THINKS THE FRONT SECTION OF BRISTLES WERE TOO STIFF FOR HER. SHE DIDN'T NOTICE ANYTHING UNUSUAL WITH THE HEAD ITSELF. SHE DIDN'T GO TO THE DENTIST BECAUSE OF THE (B)(4), BUT SHE WANTED TO MAKE SURE EVERYTHING WAS HEALED PROPERLY. THE DENTIST GAVE TIPS ON HOW TO TREAT THE CUT, BUT SHE DOESN'T REMEMBER ANY SPECIFIC DIAGNOSIS. CONSUMER WAS SENT SENSITIVE BRUSH HEADS. CONSUMER STATED THAT THE SENSITIVE BRUSH HEADS HAVE BEEN WORKING GREAT. CONSUMER IS SATISFIED USING THE (B)(4).

    Additional Manufacturer Narrative · 1

    CONSUMER HAS NOT RESPONDED TO CONTACT ATTEMPTS.

    Description of Event or Problem · 1

    ON (B)(6) 2015, CONSUMER CLAIMS SHE "GOT CUT IN MOUTH WITH THE E SERIES BRUSH HEAD AND WENT TO THE DENTIST."

    Description of Event or Problem · 1

    ON (B)(6) 2015 - CONSUMER CLAIMS SHE "GOT CUT IN MOUTH WITH THE E SERIES BRUSH HEAD AND WENT TO THE DENTIST."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515817 SONICARE E-SERIES BRUSH HEAD JEQ PHILIPS ORAL HEALTHCARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other