BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUM TRAVEL TOOTHBRUSH TWIN PACK

    MDR report key: 14349793 · Received May 10, 2022

    Report

    Report Number
    0001413787-2022-00141
    Event Type
    Malfunction
    Date Received
    May 10, 2022
    Date of Event
    November 25, 2019
    Report Date
    November 25, 2019
    Manufacturer
    SUNSTAR AMERICAS INC.
    Product Code
    EFW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR REPORT IS GENERATED RETROSPECTIVELY BASED ON COMPLAINTS AUDIT.

    Description of Event or Problem · 0

    CONSUMER PURCHASED THE GUM TRAVEL TOOTHBRUSH (DUO) AND ON THE FIRST USE, SEVERAL BRISTLES STARTED TO COME LOOSE IN HIS MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239520 GUM TRAVEL TOOTHBRUSH TWIN PACK TOOTHBRUSH, MANUAL EFW SUNSTAR AMERICAS INC. 153VZ

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown