BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDB PROXABRUSH

    MDR report key: 17769774 · Received September 18, 2023

    Report

    Report Number
    0001413787-2023-00068
    Event Type
    Malfunction
    Date Received
    September 18, 2023
    Date of Event
    September 11, 2023
    Report Date
    September 18, 2023
    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

    A CONSUMER STATED THAT THE PROXABRUSHES SHE HAD PURCHASED WERE BREAKING VERY EASILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208290 IDB PROXABRUSH TOOTHBRUSH, MANUAL EFW SUNSTAR AMERICAS INC. 1514D

    Patients

    Seq Age Sex Outcome Treatment
    1 Female