BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTEK KIDS FUN FLOSSERS, 90 CT.

    MDR report key: 23285248 · Received October 15, 2025

    Report

    Report Number
    1719513-2025-00021
    Event Type
    Injury
    Date Received
    October 15, 2025
    Manufacturer
    MEDTECH HOLDINGS, INC.
    Product Code
    JES
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    INITIAL (B)(6) 2025). THIS SERIOUS CASE REPORTED ON BAZAARVOICE REFERS TO A FEMALE CONSUMER OF UNKNOWN AGE WHO USED THE DENTEK FUN FLOSSERS FOR AN UNKNOWN INDICATION. ON AN UNREPORTED DATE, THE CONSUMER USED THE FLOSS AND REPORTED IT CAUSED SOME OF HER TOOTH TO BREAK OFF. IT IS UNKNOWN IF THE CHILD WAS SUPERVISED DURING USE. THIS CASE OUTCOME IS UNKNOWN. DUE TO THE PLATFORM THE COMPANY IS ONLY ABLE TO FOLLOW UP WITH A REPLY TO THE CONSUMER ONCE. MEDDRA VERSION 28.0 EXPECTEDNESS: TOOTH FRACTURE: UNEXPECTED. ACCORDING TO THE COMPANY REFERENCE SAFETY INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175498 DENTEK KIDS FUN FLOSSERS, 90 CT. FLOSS, DENTAL JES MEDTECH HOLDINGS, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Disability