BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDB PROXABRUSH

    MDR report key: 15254776 · Received August 18, 2022

    Report

    Report Number
    0001413787-2022-00316
    Event Type
    Malfunction
    Date Received
    August 18, 2022
    Date of Event
    December 8, 2020
    Report Date
    January 5, 2021
    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 WAS USING THE IDB PROXABRUSH AND THE WIRE BENT AND BROKE EASILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2575981 IDB PROXABRUSH TOOTHBRUSH, MANUAL EFW SUNSTAR AMERICAS INC. 614PA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown