BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARM & HAMMER SPINBRUSH PRO CLEAN

    MDR report key: 6508809 · Received April 20, 2017

    Report

    Report Number
    2280705-2017-00006
    Event Type
    Malfunction
    Date Received
    April 20, 2017
    Date of Event
    March 29, 2017
    Report Date
    April 20, 2017
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION FOR G. 1, 2 - MANUFACTURER INFORMATION IS NOT AVAILABLE BECAUSE THIS BRUSH WAS MANUFACTURED PRIOR TO THE ACQUISITION OF THESE PRODUCTS BY CHURCH & DWIGHT CO., INC. THE BRUSH WAS EXAMINED AND DETERMINED TO BE MANUFACTURED PRIOR TO THE ACQUISITION OF SPINBRUSH BRAND TOOTHBRUSHES BY CHURCH & DWIGHT CO., INC. FURTHERMORE, THE BRUSH APPEARS TO BE MANUFACTURED PRIOR TO 2005 WHEN THE FORMER OWNERS (PROCTER & GAMBLE) INITIATED A RECALL TO REDESIGN THE PLASTIC LINK IN THE BRUSH HEAD TO CORRECT THIS TYPE OF MALFUNCTION.

    Description of Event or Problem · 1

    CONSUMER REPORTS THAT THE REPLACEMENT HEAD OF THE BRUSH KEPT FALLING APART IN HIS MOUTH WHILE USING IT. CONSUMER REPORTS THE BACK PIECE THAT HOLDS THE BRISTLES ON FELL OFF OF THE REPLACEMENT HEAD THREE TIMES AND THEY HAD TO SNAP THE PLATE BACK ONTO THE HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288883 ARM & HAMMER SPINBRUSH PRO CLEAN TOOTHBRUSH, POWERED JEQ CHURCH & DWIGHT CO., INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1