BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUM BRAND SENSITIVE CLEAN TOOTHBRUSH

    MDR report key: 14349574 · Received May 10, 2022

    Report

    Report Number
    0001413787-2022-00172
    Event Type
    Malfunction
    Date Received
    May 10, 2022
    Date of Event
    September 11, 2020
    Report Date
    September 11, 2020
    Manufacturer
    SUNSTAR AMERICAS INC.
    Product Code
    EFW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR REPORT IS GENERATED RETROSPECTIVELY BASED ON COMPLAINTS AUDIT.

    Description of Event or Problem · 0

    CONSUMER PURCHASED TWO ULTRA SOFT/SENSITIVE CLEAN TOOTHBRUSHES AND EVERYTIME THEY USE IT, BRISTLES COME OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761710 GUM BRAND SENSITIVE CLEAN TOOTHBRUSH TOOTHBRUSH, MANUAL EFW SUNSTAR AMERICAS INC. 528P

    Patients

    Seq Age Sex Outcome Treatment
    1 Female