Fast Release VarnishRecalls & reported problems across all models

We found 2 models of Fast Release Varnish by 3m Company in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Jan 28, 2022 and Nov 21, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Human-Device Interface Problem” (1 report).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Fast Release Varnish recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 6, 2018Terminated

   Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product.

   Z-0368-2019 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗

Most reported Fast Release Varnish problems

Fast Release Varnish models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Fast Release Varnish 12158M

  VARNISH, CAVITY
  1 recall0 reports
• Fast Release Varnish 12158S

  VARNISH, CAVITY
  2 reports

Recent Fast Release Varnish adverse event reports

The 2 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2023Human-Device Interface Problem; Human-Device Interface Problem

  AN ALLERGIC REACTION (SYMPTOMS UNSPECIFIED) WAS REPORTED WITH 3M¿ FAST RELEASE 5% SODIUM FLUORIDE VARNISH, STRAWBERRY FLAVOR. THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS HOSPITALIZED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18185726 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SWELLING OF THE LIP, REDNESS OF THE TONGUE AND BURNING SENSATION THROUGHOUT THE BODY WAS ALLEGED THE MORNING AFTER APPLICATION OF 3M FAST RELEASE VARNISH, 5% SODIUM FLUORIDE, STRAWBERRY FLAVOR. THE SWELLING CONTINUED THE NEXT FEW DAYS, INCLUDING THE HANDS. THE DENTIST PRESCRIBED PREDNISONE (6- DAY CYCLE), AFTER WHICH THE SYMPTOMS REDUCED BUT CONTINUED. THE PATIENT PLANNED ON SEEING A DERMATOLOGIST. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Burning Sensation; Erythema; Swelling/ Edema

  MAUDE report 13389270 ↗

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