BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE PANTHERA ANTI-SNORING DEVICE

    MDR report key: 23526492 · Received November 11, 2025

    Report

    Report Number
    3009779268-2025-00001
    Event Type
    Injury
    Date Received
    November 11, 2025
    Date of Event
    September 22, 2025
    Report Date
    November 11, 2025
    Manufacturer
    PANTHERA DENTAL INC.
    Product Code
    LRK
    UDI-DI
    07540204000053
    PMA / PMN Number
    K143244
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    HE INITIALLY DEVELOPED SORES IN HIS MOUTH FROM THE APPLIANCE. HE WAS ADVISED TO DISCONTINUE CLEANING PRODUCT. PATIENT THEN ONLY USED WATER AND A BRUSH TO CLEAN IT. HE TRIED THE DEVICE AGAIN, DEVELOPED SORES INTRAORALLY, AND STARTED HAVING DIFFICULTY BREATHING. HE HAD AN ANAPHYLACTIC REACTION TO THE APPLIANCE AND HAD TO BE SEEN IN THE EMERGENCY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2545525 THE PANTHERA ANTI-SNORING DEVICE MANDIBULAR ADVANCEMENT DEVICE LRK PANTHERA DENTAL INC. 206711 07540204000053

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other