Darby Dental Supply, LLC 9430600Recalls & reported problems
Darby Dental Supply, LLC · 5% Clear Sodium Fluoride Varnish Mint 50ct · Class 2
Data updated Oct 18, 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 10889813001056), received between Apr 21, 2017 and Apr 21, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Device Handling Problem” (1 report).
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 18, 2026.
Most reported problems
Device problems
- Device Handling Problem1
- Use of Device Problem1
Patient problems
- Caustic/Chemical Burns1
- Partial thickness (Second Degree) Burn1
- Superficial (First Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 21, 2017Use of Device Problem; Device Handling Problem; Use of Device Problem; Device Handling Problem
DENTAL ASSISTANT GOT SOME OF THE PRODUCT ON THE GIRL'S FACE AND SHE WOKE UP THE NEXT MORNING WITH A BURN MARK ON HER CHEEK. THE PARENTS OF THE PATIENT CONTACTED AN ADVISE NURSE AND SENT PICTURES OF THE BURN TO HER DOCTOR FOR HIM TO REVIEW, ALONG WITH INFORMATION ABOUT THE PRODUCT. THE PARENTS WERE ADVISED TO TREAT IT AS A 1ST OR 2ND DEGREE CHEMICAL BURN AND TOOK THE ADVISE STEPS PROVIDED BY THE DOCTORS. THE PATIENT'S PARENTS ARE UNAWARE OF ANY KNOWN ALLERGIES. THE FEMALE HAD RECEIVED VARNISH TREATMENTS PREVIOUSLY. THE CLINICAL NOTES STATED THAT SHE WAS TREATED WITH VARNISH PRECIOUSLY ON (B)(6) 2015.
Patient problems: Caustic/Chemical Burns; Partial thickness (Second Degree) Burn; Superficial (First Degree) Burn
MAUDE report 6513375 ↗
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
- Fast Release Varnish 12158S3m Company · VARNISH, CAVITY2 reports
- MEDICOM DURAFLOR HALO 1015-WB32 PK6AMD Medicom Inc · VARNISH, CAVITY2 reports
- Varnish Pen - Assorted 295782Young Dental Manufacturing I, 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page