BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUM;FLS;DUAL DFNC;3YD;144/BX

    MDR report key: 14569453 · Received June 1, 2022

    Report

    Report Number
    0001413787-2022-00179
    Event Type
    Injury
    Date Received
    June 1, 2022
    Date of Event
    May 20, 2022
    Report Date
    May 20, 2022
    Manufacturer
    SUNSTAR AMERICAS INC.
    Product Code
    JES
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    CONSUMER WAS USING A SAMPLE OF THE GUM DUAL FLOSS AND WHILE USING, SHE PULLED THE FLOSS AND IT PULLED A PIECE OF HER TOOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2438372 GUM;FLS;DUAL DFNC;3YD;144/BX FLOSS, DENTAL JES SUNSTAR AMERICAS INC. 2008P

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other