BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDB PROXABRUSH

    MDR report key: 16303692 · Received February 6, 2023

    Report

    Report Number
    0001413787-2023-00007
    Event Type
    Malfunction
    Date Received
    February 6, 2023
    Date of Event
    January 25, 2023
    Report Date
    February 6, 2023
    Manufacturer
    SUNSTAR AMERICAS INC.
    Product Code
    EFW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A CONSUMER WAS USING AN IDB PROXABRUSH AND THE METAL PART WAS BREAKING AND REMAINS CAUGHT BETWEEN TEETH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136641 IDB PROXABRUSH TOOTHBRUSH, MANUAL EFW SUNSTAR AMERICAS INC. 1314D

    Patients

    Seq Age Sex Outcome Treatment
    1 Female