BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUM BRAND DEEP CLEAN TOOTHBRUSH

    MDR report key: 14349338 · Received May 10, 2022

    Report

    Report Number
    0001413787-2022-00131
    Event Type
    Malfunction
    Date Received
    May 10, 2022
    Date of Event
    July 19, 2019
    Report Date
    July 19, 2019
    Manufacturer
    SUNSTAR AMERICAS INC.
    Product Code
    EFW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    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 TECHNIQUE DEEP CLEAN TOOTHBRUSH AND THE BRISTLES STARTED TO FALL OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761707 GUM BRAND DEEP CLEAN TOOTHBRUSH TOOTHBRUSH, MANUAL EFW SUNSTAR AMERICAS INC. 525R

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown