BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERDENTAL-PROXABRUSH

    MDR report key: 14678875 · Received June 13, 2022

    Report

    Report Number
    0001413787-2022-00181
    Event Type
    Malfunction
    Date Received
    June 13, 2022
    Date of Event
    May 29, 2022
    Report Date
    May 29, 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 WAS USING A PROXABRUSH GO-BETWEEN AND AFTER A FEW USES, A WIRE OF THE BRUSH CAME OFF BETWEEN HIS TEETH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761731 INTERDENTAL-PROXABRUSH TOOTHBRUSH, MANUAL EFW SUNSTAR AMERICAS INC. 1314D

    Patients

    Seq Age Sex Outcome Treatment
    1 Male