MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS 3M¿ VANISH¿ 5% SODIUM FLUORIDE WHITE VARNISH; VARNISH, CAVITY

Model Number	12150M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	06/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No other complaints of sensitivity/allergies have been received for this lot.The lot history was reviewed, and the certificate of conformance for the materials met requirements.No ingredients related to listed allergens are contained in the product formulation.Solventum will continue to monitor.
Event or Problem Description
The patient¿s mother reported her son went into anaphylactic shock after application of 3m¿ vanish¿ 5% sodium fluoride white varnish, was seen at the emergency room (er), required treatment with epinephrine, and is now better.The dental office¿s patient coordinator later reported nupro® prophylactic paste with fluoride was also applied during the dental appointment prior to the varnish.The patient was seen at the er approximately one hour later due to a rash on the face, received epinephrine, and was released from the er that same day.

• Brand Name: 3M¿ VANISH¿ 5% SODIUM FLUORIDE WHITE VARNISH
• Common Device Name: VARNISH, CAVITY
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS; 2510 conway ave; building 275-02-w-08; st. paul MN 55144 1000
• Manufacturer Contact: yvonne mcmann ; 2510 conway ave; building 275-02-w-08; st. paul, MN 55144-1000 ; 2103743188
• MDR Report Key: 22821877
• Report Number: 3005174370-2025-00001
• Device Sequence Number: 14593683
• Product Code: LBH
• UDI-Device Identifier: 30605861013179
• UDI-Public: 0130605861013179101031251717250915
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2025

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: 09/15/2025
• Device Model Number: 12150M
• Device Catalogue Number: 12150M
• Device Lot Number: 10312517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 15 YR
• Patient Sex: Male