3M™ Cavilon™ 3342Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30707387766321), received between Feb 4, 2022 and Feb 4, 2022 — 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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2022Adverse Event Without Identified Device or Use Problem

  A CUSTOMER ALLEGED THIRD DEGREE BURNS, BLISTERS, AND ITCHINESS OF THE SKIN ON THE LOWER-RIGHT ABDOMEN, A 5X5 INCH AREA AROUND THE OSTOMY SITE, THAT OCCURRED AFTER 3M CAVILON NO STING BARRIER FILM WIPES WERE USED ONCE WHEN PROVIDING OSTOMY CARE. BABY WIPES THAT CONTAINED WATER HAD BEEN USED TO WIPE THE AREA BEFORE CAVILON WAS APPLIED. THE SYMPTOMS WERE OBSERVED FOUR DAYS LATER UPON CHANGING THE OSTOMY BAG WHEN ITCHINESS DEVELOPED. ADHESIVE REMOVER WAS PURCHASED AND APPLIED IT TO REMOVE THE CAVILON, ALONG WITH WIPING THE AREA WITH WATER AND GAUZE. THE PATIENT WAS SEEN BY A PHYSICIAN FOR THE SYMPTOMS, WHO PRESCRIBED CEPHALEXIN CAPSULES, 500MG THREE TIMES A DAY FOR TEN DAYS, AND MUPIROCIN OINTMENT, USP 2% TO APPLY THREE TIMES A DAY. THE AFFECTED AREA WAS REPORTED TO BE IMPROVING, WITH AREAS OF DRIED PUS OBSERVED.

  Patient problems: Blister; Full thickness (Third Degree) Burn; Skin Inflammation/ Irritation

  MAUDE report 13459968 ↗