BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOME TRIM SOFT TOOTHBRUSH

    MDR report key: 14316527 · Received May 7, 2022

    Report

    Report Number
    0001413787-2022-00078
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    April 18, 2022
    Report Date
    April 18, 2022
    Manufacturer
    SUNSTAR AMERICAS INC.
    Product Code
    EFW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    CONSUMER HAD BOUGHT 6 TOOTHBRUSHES AND HE STATED THAT THE BRISTLES STARTED TO FALL APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307514 DOME TRIM SOFT TOOTHBRUSH TOOTHBRUSH, MANUAL EFW SUNSTAR AMERICAS INC. 457PC

    Patients

    Seq Age Sex Outcome Treatment
    1 Male