BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDB PROXABRUSH

    MDR report key: 16690545 · Received April 6, 2023

    Report

    Report Number
    0001413787-2023-00029
    Event Type
    Malfunction
    Date Received
    April 6, 2023
    Date of Event
    March 9, 2023
    Report Date
    April 6, 2023
    Manufacturer
    SUNSTAR AMERICAS INC.
    Product Code
    EFW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A CONSUMER WAS USING THE IDB CLEANERS AND STATED THAT ALL OF THEM IN THE PACKAGE BEND AT THE NECK AND DURING USE THE HEAD BROKE OFF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1869441 IDB PROXABRUSH TOOTHBRUSH, MANUAL EFW SUNSTAR AMERICAS INC. 871FC

    Patients

    Seq Age Sex Outcome Treatment
    1 Female