BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLGATE KIDS DORA THE EXPLORER MANUAL TOOTHBRUSH

    MDR report key: 6106093 · Received November 16, 2016

    Report

    Report Number
    3003205012-2016-00018
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    November 2, 2016
    Report Date
    November 3, 2016
    Manufacturer
    COLGATE SANXIAO CO., LTD
    Product Code
    EFW
    PMA / PMN Number
    872.6855
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    INITIAL INFORMATION WAS RECEIVED ON 03NOV2016 FROM A CONSUMER'S FATHER. THIS (B)(6) YEAR OLD FEMALE CONSUMER, WITH SPECIAL NEEDS, WAS USING A COLGATE KIDS (B)(6) MANUAL TOOTHBRUSH ((B)(4)) WHEN THE TIP OF THE TOOTHBRUSH BROKE. THE CHILD BEGAN USING THE TOOTHBRUSH ON AN UNKNOWN DATE (UNKNOWN FREQUENCY). ON THE MORNING OF (B)(6) 2016, THE REPORTER'S WIFE WAS BRUSHING THE CHILD'S TEETH WHEN THE RUBBER BORDER THAT IS ON THE TIP OF THE TOOTHBRUSH CAME OFF AND ALMOST CHOKED THE CHILD. AT THE TIME OF THIS REPORT, THE ACTION TAKEN WITH THE TOOTHBRUSH WAS UNKNOWN. THIS REPORT IS REFERENCED AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758388 COLGATE KIDS DORA THE EXPLORER MANUAL TOOTHBRUSH MANUAL TOOTHBRUSH EFW COLGATE SANXIAO CO., LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other