BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINBRUSH¿ PROCLEAN¿ SONIC POWERED TOOTHBRUSH

    MDR report key: 2958515 · Received February 13, 2013

    Report

    Report Number
    2280705-2013-00012
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Report Date
    February 13, 2013
    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

    EVENT OCCURRED BETWEEN (B)(6) 2012. LOT CODES: HEAD 92312B, HANDLE DD929551. (B)(4). MANUFACTURE DATES: HEAD 08/19/2009, HANDLE 10/22/2009.

    Description of Event or Problem · 1

    CONSUMER REPORTS TOOTHBRUSH HEAD DISENGAGED DURING USE. THIS IS REPORTED AS A MALFUNCTION WITH THE POTENTIAL TO CAUSE SERIOUS INJURY. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62983 SPINBRUSH¿ PROCLEAN¿ SONIC POWERED TOOTHBRUSH TOOTHBRUSH, POWERED JEQ CHURCH & DWIGHT CO., INC. 66878 00162

    Patients

    Seq Age Sex Outcome Treatment
    1