BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA-SOFT TOOTHBRUSH WITH APPLICATOR SWAB AND CORINZ ANTISEPTIC CLEANSING & MOI

    MDR report key: 21034531 · Received December 30, 2024

    Report

    Report Number
    21034531
    Event Type
    Malfunction
    Date Received
    December 30, 2024
    Date of Event
    November 15, 2024
    Report Date
    November 15, 2024
    Manufacturer
    SAGE PRODUCTS LLC
    Product Code
    EFW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS BRUSHING HER TEETH PRE-OP WITH SAGE TOOTHBRUSH FOR ERAS AND THE BRISTLES OF THE TOOTHBRUSH WERE COMING OUT IN CLUMPS IN PATIENTS MOUTH. PATIENT WAS PULLING BRISTLES OUT FROM BETWEEN TEETH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2429564 ULTRA-SOFT TOOTHBRUSH WITH APPLICATOR SWAB AND CORINZ ANTISEPTIC CLEANSING & MOI TOOTHBRUSH, MANUAL EFW SAGE PRODUCTS LLC 98789

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female