BEUDAMED
    FDA Adverse Event Other Summary report: N

    SONICARE

    MDR report key: 2799710 · Received October 11, 2012

    Report

    Report Number
    3026630-2012-00013
    Event Type
    Other
    Date Received
    October 11, 2012
    Date of Event
    September 12, 2012
    Report Date
    October 11, 2012
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2012 SPOKE WITH CONSUMER AND REQUESTED THAT THE UNIT BE SENT IN FOR EVALUATION. CONSUMER STATED THAT NOTHING WAS LOOSE ON THE TOOTHBRUSH, JUST THE BRUSH HEAD. A RETURN LABEL WAS SENT TO THE CONSUMER FOR SHIPPING OF THE DEVICE. OCTBOER 11, 2012 HAVE NOT RECEIVED THE UNIT, WILL FILE A FOLLOW UP.

    Description of Event or Problem · 1

    (B)(6) 2012 CONSUMER STATES THAT WHILE USING THE TOOTHBRUSH THE BRUSH HEAD CAME OFF IN HER MOUTH AND HIT AN UPPER RIGHT BACK TOOTH. CONSUMER STATES THAT HER DENTIST INFORMED HER THAT THE TOOTH WAS FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONICARE FLEXCARE JEQ PHILIPS ORAL HEALTHCARE HX6910

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other