BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTADENT¿ ORAL CARE MANUAL TOOTHBRUSH

    MDR report key: 2740340 · Received September 11, 2012

    Report

    Report Number
    2280705-2012-00094
    Event Type
    Malfunction
    Date Received
    September 11, 2012
    Report Date
    October 22, 2012
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    EFW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER RETURNED PRODUCT. PACKAGING STATES THE PRODUCT WAS MANUFACTURED FOR (B)(4) WHICH INDICATES IT WAS MANUFACTURED PRIOR TO THE CHURCH & DWIGHT CO., INC. ACQUISITION. THIS IS NOT A CHURCH & DWIGHT CO., INC. PRODUCT. THIS REPORT WAS SUBMITTED OCTOBER 19, 2012. SINCE ONLY ACKNOWLEDGEMENT 1 WAS RECEIVED, IT IS BEING SUBMITTED AGAIN. THE REPORT IS NOW CALLED 2280705-2012-00094S1_(B)(4). THIS REPORT AND THE INFORMATION SUBMITTED UNDER THIS REPORT DO NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR CHURCH & DWIGHT CO., INC. OR ANY OF ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED HEREIN OR THAT THE EVENT AS REPORTED TO CHURCH & DWIGHT ACTUALLY OCCURRED.

    Description of Event or Problem · 1

    HANDLE BROKE WITH NO SIGNIFICANT INJURY; HOWEVER, IF IT 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¿ ORAL CARE MANUAL TOOTHBRUSH TOOTHBRUSH, MANUAL EFW CHURCH & DWIGHT CO., INC. 33200 01330

    Patients

    Seq Age Sex Outcome Treatment
    1