BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOOTH AND TONGUE TOOTHBRUSH

    MDR report key: 14349692 · Received May 10, 2022

    Report

    Report Number
    0001413787-2022-00159
    Event Type
    Malfunction
    Date Received
    May 10, 2022
    Date of Event
    February 1, 2021
    Report Date
    February 2, 2021
    Manufacturer
    SUNSTAR AMERICAS INC.
    Product Code
    EFW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 TOOTH AND TONGUE TOOTHBRUSH AND EVERY TIME SHE USES THE TOOTHBRUSH FOR THE FIRST TIME BRISTLES FALL OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761721 TOOTH AND TONGUE TOOTHBRUSH TOOTHBRUSH, MANUAL EFW SUNSTAR AMERICAS INC. 396RGZ

    Patients

    Seq Age Sex Outcome Treatment
    1 Female