BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINBRUSH PROCLEAN POWERED TOOTHBRUSH

    MDR report key: 2852353 · Received November 13, 2012

    Report

    Report Number
    2280705-2012-00143
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT USED WAS EITHER SPINBRUSH PROCLEAN POWERED TOOTHBRUSH SOFT (B)(4) OR SPINBRUSH PROCLEAN POWERED TOOTHBRUSH MEDIUM (B)(4). LOT CODES: HEAD DD9132H3, HANDLE DD9138F2. MFR DATES: HEAD 05/12/2009, HANDLE 05/18/2009.

    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 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 POWERED TOOTHBRUSH TOOTHBRUSH, POWERED 872.6865 JEQ CHURCH & DWIGHT CO., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1