3M™ Cavilon™ 3345Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30707387509768), received between Aug 19, 2021 and Sep 2, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fire” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2022Off-Label Use; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  A RASH (10-INCH X 6 INCH) DEVELOPED WITH REDNESS, SWELLING, BLISTERS, ITCHINESS AND BURNING SENSATION WITH USE OF 3M¿ CAVILON¿ NO STING BARRIER FILM THAT WAS APPLIED TO PROTECT AGAINST ADHESIVE IN A HEART MONITOR SINCE THE HEART MONITOR HAD CAUSED A RASH. THE RASH WAS NOTICED THE FOLLOWING DAY AND HAD SPREAD FROM THE LEFT ARMPIT TO THE NECK. THE PRODUCT WAS ON THE SKIN FOR FOUR HOURS BEFORE THE SYMPTOMS BEGAN, APPLIED ON DRY SKIN WITH NO OTHER WOUND CARE PRODUCTS APPLIED. TRIAMCINOLONE CREAM AND HYDROCORTISONE WITH EUCERINE® MOISTURIZER WAS APPLIED. THE SYMPTOMS WERE IMPROVING.

  Patient problems: Blister; Erythema; Rash; Skin Burning Sensation; Swelling/ Edema

  MAUDE report 15350656 ↗
• MalfunctionAug 5, 2022Fire; Fire

  A FLAMMABILITY EVENT WAS REPORTED WITH USE OF 3M CAVILON NO STING BARRIER FILM APPLIED AFTER SURGERY THAT WAS NOT COMPLETELY DRY DURING APPLICATION OF A WOUND VAC AND A FLASH OF FIRE OCCURRED QUICKLY WITH NO INJURY TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED UPON FOLLOW-UP ATTEMPTS WITH THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15178387 ↗
• MalfunctionAug 19, 2021Fire; Fire

  A FLAMMABILITY EVENT WAS REPORTED WITH USE OF 3M CAVILON NO STING BARRIER FILM IN AN OPERATING ROOM. NO ADDITIONAL INFORMATION WAS PROVIDED UPON FOLLOW-UP ATTEMPTS WITH THE FACILITY.

  Patient problems: Insufficient Information

  MAUDE report 12345736 ↗