BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINBRUSH¿ PROCLEAN¿ SONIC REPLACEMENT HEAD

    MDR report key: 2851525 · Received November 29, 2012

    Report

    Report Number
    2280705-2012-00170
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 25, 2012
    Report Date
    November 29, 2012
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT AND THE INFORMATION SUBMITTED UNDER THIS REPORT DO NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR CHURCH & DWIGHT CO., INC. OR ANY OF ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED HEREIN OR THAT THE EVENT AS REPORTED TO CHURCH & DWIGHT ACTUALLY OCCURRED. DEVICE NOT YET RECEIVED.

    Description of Event or Problem · 1

    CONSUMER REPORTS DAUGHTER'S TOOTHBRUSH HEAD BROKE 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
    1 SPINBRUSH¿ PROCLEAN¿ SONIC REPLACEMENT HEAD TOOTHBRUSH, POWERED JEQ CHURCH & DWIGHT CO., INC. 66878 00163 10071B

    Patients

    Seq Age Sex Outcome Treatment
    1