BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUM MICROTIP TOOTHBRUSH

    MDR report key: 14345691 · Received May 10, 2022

    Report

    Report Number
    0001413787-2022-00096
    Event Type
    Malfunction
    Date Received
    May 10, 2022
    Date of Event
    September 27, 2018
    Report Date
    September 27, 2018
    Manufacturer
    SUNSTAR AMERICAS INC.
    Product Code
    EFW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 WAS USING THE GUM MICROTIP TOOTHBRUSH AND THE BRISTLES STARTED TO PEEL OFF THE HEAD AFTER 15 DAYS OF USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1455328 GUM MICROTIP TOOTHBRUSH TOOTHBRUSH, MANUAL EFW SUNSTAR AMERICAS INC. 473MK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown