BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUM CRAYOLA TOOTHBRUSH

    MDR report key: 15217488 · Received August 12, 2022

    Report

    Report Number
    0001413787-2022-00295
    Event Type
    Injury
    Date Received
    August 12, 2022
    Date of Event
    November 16, 2018
    Report Date
    November 16, 2018
    Manufacturer
    SUNSTAR AMERICAS INC.
    Product Code
    EFW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR REPORT IS GENERATED RETROSPECTIVELY BASED ON COMPLAINTS AUDIT.

    Description of Event or Problem · 0

    CONSUMER WAS USING A GUM CRAYOLA TOOTHBRUSH TO BRUSH HIS CHILDS TEETH AND THE BRISTLES FELL OUT AND MADE HIM CHOKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2790594 GUM CRAYOLA TOOTHBRUSH TOOTHBRUSH, MANUAL EFW SUNSTAR AMERICAS INC. 232KK

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other