BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUM DEEP CLEAN TOOTHBRUSH

    MDR report key: 13047892 · Received December 20, 2021

    Report

    Report Number
    0001413787-2021-00017
    Event Type
    Injury
    Date Received
    December 20, 2021
    Date of Event
    May 7, 2019
    Report Date
    May 7, 2019
    Manufacturer
    SUNSTAR AMERICAS, INC.
    Product Code
    EFW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    I HAVE A CHILD OF (B)(6) YEARS OLD THAT TODAY ALMOST LOST BY THE TOOTHBRUSH THAT YOU DISTRIBUTE. I STILL TREMBLE TO REMEMBER HOW MY SON WAS DROWNING AND UNABLE TO DO ANYTHING BECAUSE THE BRUSH BROKE WHILE HE BRUSHED HIS TONGUE AND STAYED IN HIS THROAT.

    Description of Event or Problem · 0

    I HAVE A CHILD OF (B)(6) YEARS OLD THAT TODAY ALMOST LOST BY THE TOOTHBRUSH THAT YOU DISTRIBUTE. I STILL TREMBLE TO REMEMBER HOW MY SON WAS DROWNING AND UNABLE TO DO ANYTHING BECAUSE THE BRUSH BROKE WHILE HE BRUSHED HIS TONGUE AND STAYED IN HIS THROAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1940879 GUM DEEP CLEAN TOOTHBRUSH TOOTHBRUSH EFW SUNSTAR AMERICAS, INC. 524KM

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Male Other