BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINBRUSH PROCLEAN RECHARGE

    MDR report key: 2852332 · Received November 13, 2012

    Report

    Report Number
    2280705-2012-00132
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTS TOOTHBRUSH HEAD BREAKAGE DURING USE. THIS IS REPORTED AS A MALFUNCTION WITH THE POTENTIAL TO CAUSE SERIOUS INJURY. NO INJURY OCCURRED. THIS IS BEING SUBMITTED AS PART OF A 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 PROCLEAN RECHARGE TOOTHBRUSH, POWERED SECTION 872.6865 (JEQ) JEQ CHURCH & DWIGHT CO., INC. 66878 00160

    Patients

    Seq Age Sex Outcome Treatment
    1