Varnish Pen - Assorted 295782Recalls & reported problems
Young Dental Manufacturing I, LLC · 45 count · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10302732957827), received between May 14, 2018 and May 14, 2018 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Inflammation1
- Local Reaction1
- Rash1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT RETURNED FOR A FOLLOW UP APPOINTMENT AFTER HER HYGIENE APPOINTMENT A WEEK BEFORE. FOLLOWING THE APPOINTMENT, SHE BROKE OUT IN SORES ON THE INSIDE OF HER LIPS AND THINKS IT IS DUE TO THE VARNISH PEN. SHE HASN'T HAD VARNISH USED FOR OVER 2 YEARS AND HAS A KNOWN HISTORY OF LATEX/RUBBER ALLERGY. THE VARNISH PEN WAS USED ON HER, WHICH WAS THE ONLY NEW THING USED. ALL OTHER PRODUCTS USED HAVE BEEN USED ON HER BEFORE. THE PATIENT IS FEMALE IN HER (B)(6) AND HAS BEEN TAKING BENADRYL TO TREAT THE SORES. THE SORES WERE STILL PRESENT DURING THE FOLLOW UP APPOINTMENT. THE VARNISH PEN IS COMPRISED OF VARNISH, AN ALUMINUM TUBE, AND PLASTIC. THERE IS NO KNOWN PRESENCE OF LATEX IN THE MAKEUP OF THESE PARTS. THERE IS NO EVIDENCE THAT SUGGESTS THE POSSIBLE REACTION WAS DUE TO THE VARNISH PEN. BENADRYL WAS USED TO REDUCE THE EFFECTS OF THE POSSIBLE ALLERGIC REACTION THAT OCCURED AFTER THE HYGIENE APPOINTMENT. IT HAS NOT BEEN CONCLUDED THAT IMPAIRMENT OR PERMANENT DAMAGE COULD HAVE OCCURRED IF MEDICATION HAD NOT BEEN USED. HOWEVER, SINCE AN ADDITIONAL PRECAUTION WAS USED, WE BELIEVE THE EVENT IS REPORTABLE. THIS EVENT DID NOT RESULT IN SERIOUS INJURY TO THE PATIENT.
Patient problems: Inflammation; Local Reaction; Rash
MAUDE report 7512257 ↗
Other Varnish, Cavity devices
- Fast Release Varnish 12158M3m Company · VARNISH, CAVITY1 recall0 reports
- IRIS 4323-635Benco Dental Supply CO. · Varnish, Cavity1 recall0 reports
- Philips Zoom! Chairside Light-Activated Whitening Kit DIS556Discus Dental, LLC · VARNISH, CAVITY8 reports
- Philips Zoom! Chairside Light-Activated Whitening Kit DIS557Discus Dental, LLC · VARNISH, CAVITY7 reports
- MEDICOM DURAFLOR HALO 1015-WB32 PK6AMD Medicom Inc · VARNISH, CAVITY2 reports
- Fast Release Varnish 12158S3m Company · VARNISH, CAVITY2 reports
- Listerine 00312547235952Kenvue Brands LLC · VARNISH, CAVITY1 report
- Vanish™ 12150M3m Company · VARNISH, CAVITY1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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