BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONICARE

    MDR report key: 4454394 · Received January 23, 2015

    Report

    Report Number
    3026630-2015-00006
    Event Type
    Injury
    Date Received
    January 23, 2015
    Date of Event
    January 5, 2015
    Report Date
    January 23, 2015
    Manufacturer
    PHILIPS ORAL HEALTHCARE, INC.
    Product Code
    JEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015 CONSUMER STATES THAT SHE HAS BEEN USING THE UNIT FOR 2 WEEKS. CONSUMER STATES THAT SHE WENT TO A DENTAL SCHOOL AND THEY FILLED THE TOOTH. CONSUMER IS UNSURE HOW THE TOOTH WAS CHIPPED, HOWEVER, BELIEVES THAT IT WAS CAUSED BY THE TOOTHBRUSH. CONSUMER STATES THAT HER LAST VISIT TO THE DENTIST WAS IN (B)(6) 2013 DUE TO A PROBLEM WITH HER WISDOM TEETH. CONSUMER STATES THAT SHE DID NOT GET HER TEETH CLEANED DURING THAT VISIT. CONSUMER HAS AGREED TO RETURN THE UNIT FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2015 CUSTOMER CLAIMS HE BELIEVES THE SONICARE BROKE HIS TOOTH. HE CLAIMS IT IS THE CAUSE OF HIM LOOSING A PIECE OF HIS RIGHT, BOTTOM TOOTH ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53693 SONICARE E-SERIES 2.0 JEQ PHILIPS ORAL HEALTHCARE, INC. HX6210

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK