BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINBRUSH PROCLEAN POWERED TOOTHBRUSH

    MDR report key: 2509900 · Received March 29, 2012

    Report

    Report Number
    2280705-2012-00026
    Event Type
    Injury
    Date Received
    March 29, 2012
    Report Date
    March 29, 2012
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INDEPENDENT DENTAL EXPERTS HAVE CONCLUDED THAT THE SPINBRUSH TOOTHBRUSH DOES NOT EXERT SUFFICIENT FORCE TO CAUSE A TOOTH TO CHIP OR BREAK, VENEERS TO BE REMOVED, OR CAPS/CROWNS TO BE DISLODGED; UNDERLYING DENTAL PATHOLOGY OR POOR DENTAL PRACTICES ARE RESPONSIBLE. 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 BY CHURCH & DWIGHT CO., INC., ACTUALLY OCCURRED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    CONSUMER REPORTS THE TOOTHBRUSH BROKE HIS TOOTH WHILE BRUSHING. THIS WAS IDENTIFIED DURING OUR RETROSPECTIVE REVIEW TO IDENTIFY MALFUNCTIONS WITH THE POTENTIAL TO CAUSE SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINBRUSH PROCLEAN POWERED TOOTHBRUSH TOOTHBRUSH, POWERED JEQ CHURCH & DWIGHT CO., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other