BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUM BRAND DEEP CLEAN TOOTHBRUSH

    MDR report key: 14349468 · Received May 10, 2022

    Report

    Report Number
    0001413787-2022-00134
    Event Type
    Malfunction
    Date Received
    May 10, 2022
    Date of Event
    August 2, 2019
    Report Date
    August 2, 2019
    Manufacturer
    SUNSTAR AMERICAS INC.
    Product Code
    EFW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 WAS USING THE GUM DEEP CLEAN TOOTHBRUSH RECEIVED FROM HER DENTIST AND THE BRISTLES STARTED TO FALL OUT AFTER HER FIRST TIME USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2812943 GUM BRAND DEEP CLEAN TOOTHBRUSH TOOTHBRUSH, MANUAL EFW SUNSTAR AMERICAS INC. 525RYA

    Patients

    Seq Age Sex Outcome Treatment
    1 Female