BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONICARE

    MDR report key: 3835845 · Received May 12, 2014

    Report

    Report Number
    3026630-2014-00013
    Event Type
    Injury
    Date Received
    May 12, 2014
    Date of Event
    April 16, 2014
    Report Date
    May 12, 2014
    Manufacturer
    PHILIPS ORAL HEALTHCARE, INC.
    Product Code
    JEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6), 2014 CUSTOMER CLAIMS THAT SHE THINKS HER HUSBAND CLEANS THE UNIT MORE OFTEN TO MAKE SURE THERE WASN'T ANYTHING IN IT. CUSTOMER CLAIMS THAT HE HAS BEEN USING THE UNIT SINCE (B)(6) AND HAS BEEN TO THE DOCTOR 3 TIMES FOR THROAT INFECTION WITH BLISTERS INSIDE HIS MOUTH. CUSTOMER STATES THAT THE DOCTOR ASKED IF HE WAS USING ANYTHING INSIDE HIS MOUTH AND ONLY THOUGHT ABOUT THE TOOTHBRUSH; CLAIMS THAT THE DENTIST ALSO TOLD HIM NOT TO USE THE PRODUCT BECAUSE MOLD WOULD CAUSE INFECTIONS. CUSTOMER STATED THAT THEY AGREED TO RETURN UNIT. ISSUING (B)(6) RETURN LABEL/LETTER AND REQUEST FOR DENTAL INFORMATION VIA WHITE MAIL.

    Description of Event or Problem · 1

    (B)(6), 2014 CUSTOMER CLAIMS THAT HER HUSBAND HAS BEEN EXPERIENCING THROAT INFECTIONS POSSIBLY DUE TO THE MOLD BUILD UP IN HIS UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283408 SONICARE CLEANCARE/ESSENCE JEQ PHILIPS ORAL HEALTHCARE, INC. HX5610

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other