BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINBRUSH¿ PROCLEAN POWERED TOOTHBRUSH

    MDR report key: 2633638 · Received June 28, 2012

    Report

    Report Number
    2280705-2012-00075
    Event Type
    Malfunction
    Date Received
    June 28, 2012
    Report Date
    August 24, 2012
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT OCCURRED BETWEEN (B)(6) 2012. THE PRODUCT USED WAS EITHER SPINBRUSH PROCLEAN TOOTHBRUSH SOFT 66878 00078, SPINBRUSH PROCLEAN TOOTHBRUSH MEDIUM 66878 00079, SPINBRUSH PRO WHITENING TOOTHBRUSH SOFT 66878 00191 OR SPINBRUSH PRO WHITENING TOOTHBRUSH MEDIUM 66878 00193. THE CONSUMER HAS NOT RETURNED THE PRODUCT TO DATE, THEREFORE, WE ARE UNABLE TO DETERMINE THE EXACT PRODUCT THAT WAS USED. THE PRODUCT WAS MANUFACTURED AT ONE OF THE FOLLOWING LOCATIONS. SINCE THE CONSUMER HAS NOT RETURNED THE PRODUCT TO DATE WE ARE UNABLE TO DETERMINE AT WHICH LOCATION THIS PARTICULAR PRODUCT WAS MADE. (B)(4).

    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 DD1104H1, HANDLE DD1104E1. MANUFACTURE DATES: HEAD 4/14/2011, HANDLE 4/14/2011.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINBRUSH¿ PROCLEAN POWERED TOOTHBRUSH TOOTHBRUSH, POWERED JEQ CHURCH & DWIGHT CO., INC. DD1104E1

    Patients

    Seq Age Sex Outcome Treatment
    1