MAUDE Adverse Event Report: YOUNG DENTAL MANUFACTURING 1, LLC YOUNG CLEARDEFENSE 8ML; VARNISH

Catalog Number	296906
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Young dental has not received any other complaints or notifications of an allergic reaction for this product.
Event or Problem Description
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.

• Brand Name: YOUNG CLEARDEFENSE 8ML
• Common Device Name: VARNISH
• Manufacturer (Section D): YOUNG DENTAL MANUFACTURING 1, LLC; 13705 shoreline ct. e; earth city MO 63045
• Manufacturer (Section G): YOUNG DENTAL MANUFACTURING 1, LLC; 13705 shoreline ct. e; earth city MO 63045
• Manufacturer Contact: jose espino ; 13705 shoreline ct. e; earth city, MO 63045 ; 3143440010
• MDR Report Key: 23974321
• Report Number: 1941138-2025-00001
• Device Sequence Number: 21508942
• Product Code: PHR
• UDI-Device Identifier: 00302730003307
• UDI-Public: 00302730003307
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/21/2026
• Device Catalogue Number: 296906
• Device Lot Number: 276085
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 15 YR
• Patient Sex: Female