BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUM CRAYOLA TOOTHBRUSH, MARKER, METALLIC

    MDR report key: 11893692 · Received May 27, 2021

    Report

    Report Number
    0001413787-2021-00008
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    April 22, 2021
    Report Date
    April 23, 2021
    Manufacturer
    SUNSTAR AMERICAS INC.
    Product Code
    EFW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORRECTIONS TO THE ORIGINAL MDR SUBMITTED ARE AS FOLLOWS: 1. SECTION B.1. - ADDED ADVERSE EVENT. 2. SECTION B.3. - ADDED DATE OF EVENT - 04/22/2021. 3. SECTION B.4. - CORRECTED DATE OF REPORT - 04/23/2021. 4. SECTION G.3. - ADDED DATE RECIEVED Y MANUFACTURER - 04/23/2021. 5. SECTION G.7. - ADDED ADVERSE EVENT TERMS - BRISTLES STUCK BETWEEN TOOTH. 6. SECTION H.6. - ADDED ADVERSE PROBLEM CODES - 3165, 4613.

    Description of Event or Problem · 0

    I BOUGHT A DOUBLE PACK OF CHILDREN'S CRAYOLA TOOTHBRUSHES. MY GRANDDAUGHTER WHO IS 3 BRUSHED HER TEETH AND A BRISTLE FROM THE TOOTHBRUSH GOT STUCK IN HER TOOTH. I GOT IT OUT BUT I DON'T THINK THIS SHOULD HAVE HAPPENED. IT WAS MAYBE 1/2 INCH LONG IN A U SHAPE.

    Description of Event or Problem · 1

    I BOUGHT A DOUBLE PACK OF CHILDREN'S CRAYOLA TOOTHBRUSHES. MY GRANDDAUGHTER WHO IS 3 BRUSHED HER TEETH AND A BRISTLE FROM THE TOOTHBRUSH GOT STUCK IN HER TOOTH. I GOT IT OUT BUT I DON'T THINK THIS SHOULD HAVE HAPPENED. IT WAS MAYBE 1/2 INCH LONG IN A U SHAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795264 GUM CRAYOLA TOOTHBRUSH, MARKER, METALLIC TOOTHBRUSH, MANUAL EFW SUNSTAR AMERICAS INC. 227KKM

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Female