BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINBRUSH PROCLEAN SONIC POWERED TOOTHBRUSH

    MDR report key: 2030433 · Received March 18, 2011

    Report

    Report Number
    2280705-2011-00014
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 17, 2011
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BODY WAS MADE AT THE FOLLOWING LOCATION. CONTACT MFR: (B)(4). CONCLUSION: CONSUMER HAS NOT RETURNED PRODUCT TO DATE, THEREFORE, IT COULD NOT BE EVALUATED AND NO CONCLUSIONS COULD BE DRAWN.

    Description of Event or Problem · 1

    CONSUMER REPORTED: WHILE USING THE BRUSH, THE HEAD RELEASED AND THE METAL PROBE CAUSED DAMAGE TO HER PALATE AND CHIPPED A FRONT TOOTH. THE HEAD ALSO RELEASED WHEN SHE TURNED THE BRUSH ON WITHOUT BRUSHING. NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINBRUSH PROCLEAN SONIC POWERED TOOTHBRUSH TOOTHBRUSH, POWERED SEC 872.6865 (JEQ) JEQ CHURCH & DWIGHT CO., INC. 6687800162 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other