BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROCLEAN SPINBRUSH SONIC

    MDR report key: 2020236 · Received March 9, 2011

    Report

    Report Number
    2280705-2011-00011
    Event Type
    Other
    Date Received
    March 9, 2011
    Date of Event
    April 1, 2010
    Report Date
    March 10, 2011
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT #: BODY #DD9278J2. HEAD MADE AT FOLLOWING CONTRACT MFR LOCATION: (B)(4). BODY MADE AND PRODUCT ASSEMBLED AT FOLLOWING CONTRACT MFR LOCATION: (B)(4). APPEARS CONSUMER WAS OVERLY AGGRESSIVE IN BRUSHING. BRUSH HEAD DISENGAGED FROM BODY. PULL-OFF FORCE BELOW SPECIFICATION; BATCH RECORD SHOWS WITHIN SPEC AT TIME OF RELEASE. OVERLY AGGRESSIVE BRUSHING.

    Description of Event or Problem · 1

    REPORTED AT THE REQUEST OF FDA INVESTIGATOR, (B)(6); COMPANY DOES NOT CONSIDER THIS TO BE A REPORTABLE SERIOUS INJURY NOR A REPORTABLE MALFUNCTION. CONSUMER REPORTED WHILE BRUSHING TEETH WITH PRODUCT FOR THE FIRST TIME, THE BRUSH HEAD DISENGAGED AND THE METAL ROD CUT AND PUNCTURED HER UPPER EYELID; CONSUMER APPLIED PRESSURE AT WOUND SITE, CLEANSED AND BANDAGED; NO PROFESSIONAL MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCLEAN SPINBRUSH SONIC TOOTHBRUSH, POWERED S872.6865 (JEQ) JEQ CHURCH & DWIGHT CO., INC. 66878-00162 92541C

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR