BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCITEOSA

    MDR report key: 18384046 · Received December 22, 2023

    Report

    Report Number
    3017737771-2023-00028
    Event Type
    Injury
    Date Received
    December 22, 2023
    Report Date
    May 5, 2023
    Manufacturer
    SIGNIFIER MEDICAL TECHNOLOGIES
    Product Code
    QNO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT HAS STOPPED USE OF THE DEVICE AND HAS REPORTED THEIR JAW IS IMPROVING. FOLLOW UP REPORT TO BE PROVIDED AS SOON AS POSSIBLE.

    Description of Event or Problem · 0

    USER EXPERIENCED ACUTE TMJ, OPEN LOCK AND SLIP OF JAW ON THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1325077 EXCITEOSA EXCITEOSA QNO SIGNIFIER MEDICAL TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown