BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDB PROXABRUSH

    MDR report key: 16708356 · Received April 10, 2023

    Report

    Report Number
    0001413787-2023-00028
    Event Type
    Malfunction
    Date Received
    April 10, 2023
    Date of Event
    April 4, 2023
    Report Date
    April 10, 2023
    Manufacturer
    SUNSTAR AMERICAS INC.
    Product Code
    EFW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A CONSUMER WAS AN IDB PROXABRUSH AND STATED THAT THE BRISTLES WERE FALLING OUT WHILE USING THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1754025 IDB PROXABRUSH TOOTHBRUSH, MANUAL EFW SUNSTAR AMERICAS INC. 3612FC

    Patients

    Seq Age Sex Outcome Treatment
    1 Male