BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUM TECH GUM HEALTH COMP 1CT

    MDR report key: 23659776 · Received November 26, 2025

    Report

    Report Number
    1413787-2025-00244
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    November 5, 2025
    Report Date
    November 26, 2025
    Manufacturer
    SUNSTAR AMERICAS, INC
    Product Code
    EFW
    UDI-DI
    00070942008112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    CUSTOMER USED BRUSH AND BRISTLES CAME OUT IN THEIR MOUTH CAUSING THEM TO CHOKE AND VOMIT. THEIR PARTNER HELPED THEM AS BRISTLES GOT CAUGHT IN THEIR MOUTH AND HELPED HER RINSE HER MOUTH. CUSTOMER VISITED DOCTOR DUE TO HAVING A VERY IRRITATED THROAT AND HAVE BEEN PRESCRIBED A BENZYDAMINE MOUTH WASH FOR THE PAIN AND INFLAMMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2812350 GUM TECH GUM HEALTH COMP 1CT MANUAL TOOTHBRUSH EFW SUNSTAR AMERICAS, INC 525TPA1 00070942008112

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other