BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINBRUSH¿ PROCLEAN¿ POWERED TOOTHBRUSH

    MDR report key: 3027024 · Received March 29, 2013

    Report

    Report Number
    2280705-2013-00025
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Report Date
    March 29, 2013
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT USED WAS EITHER SPINBRUSH PROCLEAN POWERED TOOTHBRUSH SOFT 66878 00078 OR SPINBRUSH PROCLEAN. POWERED TOOTHBRUSH MEDIUM 66878 00079. LOT CODES: HEAD DD2280G1, HANDLE DD2285F1 MANUFACTURE DATES: HEAD 10/06/2012, HANDLE 10/11/2012.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130229 SPINBRUSH¿ PROCLEAN¿ POWERED TOOTHBRUSH TOOTHBRUSH, POWERED JEQ CHURCH & DWIGHT CO., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1