BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINBRUSH

    MDR report key: 1760372 · Received June 23, 2010

    Report

    Report Number
    2280705-2010-00004
    Event Type
    Injury
    Date Received
    June 23, 2010
    Date of Event
    May 28, 2010
    Report Date
    May 28, 2010
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE CONSUMER HAS NOT RETURNED THE PRODUCT TO DATE WE ARE UNABLE TO DETERMINE AT WHICH LOCATION THIS PARTICULAR PRODUCT WAS MADE. (B)(4). CONSUMER HAS NOT RETURNED PRODUCT TO DATE, THEREFORE, IT COULD NOT BE EVALUATED AND NO CONCLUSIONS COULD BE DRAWN. THIS REPORT AND THE INFORMATION SUBMITTED UNDER THIS REPORT DOES 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

    CONSUMER REPORTED HIS TOOTH BROKE WHILE USING THE BRUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINBRUSH TOOTHBRUSH, POWERED SECTION 872.6865 (JEQ) JEQ CHURCH & DWIGHT CO., INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability