BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONICARE

    MDR report key: 4281600 · Received November 20, 2014

    Report

    Report Number
    3026630-2014-00032
    Event Type
    Malfunction
    Date Received
    November 20, 2014
    Date of Event
    October 15, 2014
    Report Date
    November 5, 2014
    Manufacturer
    PHILIPS ORAL HEALTHCARE, INC.
    Product Code
    JEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON OCTOBER 15, 2014, CONSUMER HAS AGREED TO RETURN THE PRODUCT FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER CLAIMS TWO BRUSH HEADS CRACKED WITHIN FIRST TWO DAYS OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753587 SONICARE SENSITIVE BRUSH HEAD JEQ PHILIPS ORAL HEALTHCARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK