BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINBRUSH¿ PROCLEAN¿ SONIC RECHARGE POWERED TOOTHBRUSH

    MDR report key: 3061699 · Received April 16, 2013

    Report

    Report Number
    2280705-2013-00029
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE HEAD WAS MADE AT THE FOLLOWING LOCATION. (B)(4). THE HANDLE AND CHARGER WERE MADE AT THE FOLLOWING LOCATION. (B)(4). ADDITIONAL INFORMATION: ON (B)(6) 2013, WE RECEIVED THE REPORT WHICH CONTAINED GENERIC INFORMATION FOR THE DEVICE NAME AND DESCRIPTION OF THE EVENT. THE INFORMATION PROVIDED DID NOT REASONABLY SUGGEST THAT THE MARKETED DEVICE HAD MALFUNCTIONED IN A MANNER THAT WERE THE MALFUNCTION TO RECUR IT COULD RESULT IN SERIOUS INJURY. ON (B)(6) 2013, WE RECEIVED ADDITIONAL INFORMATION WHICH INDICATED THAT THE DEVICE THE CONSUMER DESCRIBED IN THE ORIGINAL REPORT IS SPINBRUSH PROCLEAN SONIC RECHARGE POWERED TOOTHBRUSH. THE EVENTS DESCRIBED FOR THAT MODEL ARE CONSISTENT WITH A REPORTABLE MALFUNCTION. (B)(6) 2013 IS OUR AWARE DATE AS THE INFORMATION OBTAINED SUGGESTED THAT THE MARKETED DEVICE HAD A MALFUNCTION.

    Description of Event or Problem · 1

    CONSUMER REPORTS TOOTHBRUSH HEAD DISENGAGED 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
    162259 SPINBRUSH¿ PROCLEAN¿ SONIC RECHARGE POWERED TOOTHBRUSH TOOTHBRUSH, POWERED JEQ CHURCH & DWIGHT CO., INC. 66878 00940

    Patients

    Seq Age Sex Outcome Treatment
    1