BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUM® TECHNIQUE® COMPLETE CARE COMPACT/SENSITIVE TOOTHBRUSH

    MDR report key: 22896340 · Received August 26, 2025

    Report

    Report Number
    1413787-2025-00223
    Event Type
    Injury
    Date Received
    August 26, 2025
    Date of Event
    July 31, 2025
    Report Date
    August 26, 2025
    Manufacturer
    SUNSTAR AMERICAS, INC
    Product Code
    EFW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    CUSTOMER COMPLAINED WAS BRUSHING HER TEETH WITH OUR 595 TOOTHBRUSH WHEN A 2-INCH PIECE BROKE OFF AND WAS LODGED IN HER THROAT. HER BOYFRIEND PERFORMED THE HEIMLICH MANEUVER ON HER WHERE SHE PROCEEDED TO SWALLOW THE PIECE. SHE VISITED 2 DAYS IN THE HOSPITAL BEING MONITORED AND TRACKING THE PIECE WHEN SHE WAS FINALLY ABLE TO PASS IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1866502 GUM® TECHNIQUE® COMPLETE CARE COMPACT/SENSITIVE TOOTHBRUSH MANUAL TOOTHBRUSH EFW SUNSTAR AMERICAS, INC 595PC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other