BEUDAMED
    FDA Adverse Event Injury Summary report: N

    YOUNG CLEARDEFENSE 8ML

    MDR report key: 23974321 · Received January 6, 2026

    Report

    Report Number
    1941138-2025-00001
    Event Type
    Injury
    Date Received
    January 6, 2026
    Date of Event
    November 19, 2025
    Report Date
    December 18, 2025
    Manufacturer
    YOUNG DENTAL MANUFACTURING 1, LLC
    Product Code
    PHR
    UDI-DI
    00302730003307
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    YOUNG DENTAL HAS NOT RECEIVED ANY OTHER COMPLAINTS OR NOTIFICATIONS OF AN ALLERGIC REACTION FOR THIS PRODUCT.

    Description of Event or Problem · 0

    PATIENT HAD SWELLING UNDER THE LEFT EYE AND CHEEK 30 MINUTES AFTER BEING TREATED WITH CLEAR DEFENSE PRODUCT IN UPPER LEFT QUADRANT OF MOUTH OF ONE .05ML DROP ACROSS THREE MAXILLARY TEETH FOR TREATING "HYPERSENSITIIVTY." 4% ARTICAINE 1:100,000 EPI LOWER LEFT QUADRANT ALSO USED AT DENTAL VISIT. PATIENT WENT TO URGENT CARE AND WAS DIAGNOSED WITH AN ALLERGIC REACTION AND WAS SUCCESSFULLY TREATED WITH BENADRYL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38590 YOUNG CLEARDEFENSE 8ML VARNISH PHR YOUNG DENTAL MANUFACTURING 1, LLC 276085 00302730003307

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Female Required Intervention