BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINBRUSH¿ PROCLEAN¿ POWERED TOOTHBRUSH

    MDR report key: 2943882 · Received February 5, 2013

    Report

    Report Number
    2280705-2013-00010
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Report Date
    March 28, 2013
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE INFORMATION: LOT CODES: HEAD DD1167H1, HANDLE DD1166E2; MANUFACTURE DATES: HEAD 06/16/2011, HANDLE 06/15/2011.

    Description of Event or Problem · 1

    CONSUMER REPORTS TOOTHBRUSH HEAD BREAKAGE. THIS IS REPORTED AS A MALFUNCTION WITH THE POTENTIAL TO CAUSE SERIOUS INJURY. NO INJURY OCCURRED. INVESTIGATION INDICATES OVERUSE ERROR (BRUSH WEAR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47888 SPINBRUSH¿ PROCLEAN¿ POWERED TOOTHBRUSH TOOTHBRUSH, POWERED JEQ CHURCH & DWIGHT CO., INC. 66878 00079

    Patients

    Seq Age Sex Outcome Treatment
    1 Other