BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBD MODERATE RET

    MDR report key: 14573282 · Received June 2, 2022

    Report

    Report Number
    0001413787-2022-00174
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Date of Event
    May 4, 2022
    Report Date
    May 4, 2022
    Manufacturer
    SUNSTAR AMERICAS INC.
    Product Code
    EFW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    CONSUMER WAS USING THE PROXABRUSH AND THE WIRES STARTED TO COME OUT AFTER A WHILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265687 IBD MODERATE RET TOOTHBRUSH, MANUAL EFW SUNSTAR AMERICAS INC. 3612FC

    Patients

    Seq Age Sex Outcome Treatment
    1 Male