BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUM ADVANCED CARE FLOSSER

    MDR report key: 13029201 · Received December 17, 2021

    Report

    Report Number
    0001413787-2021-00015
    Event Type
    Injury
    Date Received
    December 17, 2021
    Date of Event
    May 12, 2021
    Report Date
    November 22, 2021
    Manufacturer
    SUNSTAR AMERICAS, INC.
    Product Code
    JES
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    MY HUSBAND'S TOOTH THE SECOND TIME IT BROKE FROM YOUR PRODUCT WITHIN A COUPLE OF DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1925982 GUM ADVANCED CARE FLOSSER FLOSSER JES SUNSTAR AMERICAS, INC. 888RXX

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other| S