BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINBRUSH PRO WHITENING POWERED TOOTHBRUSH

    MDR report key: 2852357 · Received November 13, 2012

    Report

    Report Number
    2280705-2012-00140
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Report Date
    November 12, 2012
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT USED WAS EITHER SPINBRUSH PRO WHITENING TOOTHBRUSH SOFT (B)(4) OR SPINBRUSH PRO WHITENING TOOTHBRUSH MEDIUM (B)(4). THERE IS NO CODE AVAILABLE THAT BEST FITS THE CONCLUSION.

    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. THIS IS BEING SUBMITTED AS PART OF 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 PRO WHITENING POWERED TOOTHBRUSH TOOTHBRUSH, POWERED 872.6865 JEQ CHURCH & DWIGHT CO., INC. DD1213H1

    Patients

    Seq Age Sex Outcome Treatment
    1