BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINBRUSH PRO WHITENING POWERED TOOTHBRUSH

    MDR report key: 2852373 · Received November 13, 2012

    Report

    Report Number
    2280705-2012-00149
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT USED WAS EITHER SPINBRUSH PRO WHITENING TOOTHBRUSH SOFT (B)(4) OR SPINBRUSH PRO WHITENING TOOTHBRUSH MEDIUM (B)(4). FINDINGS: BOTH OSCILLATING HEAD AND TRANSLATING PLATE HAS COME FREE. ORIGINAL BRUSH HEAD SINCE THERE IS NO DATE CODE. BRUSH NOT RETURNED.

    Description of Event or Problem · 1

    CONSUMER REPORTS TOOTHBRUSH HEAD BREAKAGE. 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 PRO WHITENING POWERED TOOTHBRUSH TOOTHBRUSH, POWERED SEC 872.6865 (JEQ) JEQ CHURCH & DWIGHT CO., INC. SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1