BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINBRUSH¿ PRO WHITENING¿ POWERED TOOTHBRUSH

    MDR report key: 2944484 · Received February 5, 2013

    Report

    Report Number
    2280705-2013-00011
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE: TOOTHBRUSH HEAD HAS BEEN DETERMINED TO BE ONE MANUFACTURED BY P&G PRIOR TO OUR ACQUISITION OF SPINBRUSH. IT IS PART OF ONE OF THE FOLLOWING RECALLS: Z-0377-05, Z-0376-05, Z-0378-05, OR Z-0375-05. ADDITIONAL DEVICE INFORMATION: LOT CODE PROVIDED IS FOR HANDLE. THE HANDLE WAS MANUFACTURED AT ONE OF THE FOLLOWING LOCATIONS. CONTRACT MANUFACTURER: HAYCO LTD. (B)(4); CONTRACT MANUFACTURER: SHANTOU PLASTIC CO., LTD. (B)(4). DEVICE MANUFACTURE DATE PROVIDED IS FOR HANDLE.

    Description of Event or Problem · 1

    CONSUMER REPORTS TOOTHBRUSH HEAD BREAKAGE DURING USE. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49347 SPINBRUSH¿ PRO WHITENING¿ POWERED TOOTHBRUSH TOOTHBRUSH, POWERED JEQ CHURCH & DWIGHT CO., INC. 66878 00191 DD7147B1

    Patients

    Seq Age Sex Outcome Treatment
    1