BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTADENT¿ WHITE & CLEAN MANUAL TOOTHBRUSH

    MDR report key: 2860981 · Received December 6, 2012

    Report

    Report Number
    2280705-2012-00172
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Report Date
    December 5, 2012
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    EFW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONSUMER REPORTS TWO TOOTHBRUSHES BROKE DURING USE. MINOR INJURIES (STABBED HIM ON THE GUMS AND LIP) OCCURRED. IF THIS WERE TO RECUR THERE IS A POTENTIAL TO CAUSE SIGNIFICANT INJURY - CHOKING HAZARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTADENT¿ WHITE & CLEAN MANUAL TOOTHBRUSH TOOTHBRUSH, MANUAL EFW CHURCH & DWIGHT CO., INC. 33200 05070

    Patients

    Seq Age Sex Outcome Treatment
    1