3M™ Cavilon™ 5050 (UDI 50707387773361)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 50707387773361), received between Dec 5, 2020 and Jun 29, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2023Improper or Incorrect Procedure or Method; Patient Device Interaction Problem; Improper or Incorrect Procedure or Method; Patient Device Interaction Problem

  SKIN STRIPPING DESCRIBED AS PARTIAL THICKNESS SKIN DAMAGE ON THE AREA COVERED BY 3M¿ CAVILON¿ ADVANCED SKIN PROTECTANT. SKIN STRIPPING WITH REDNESS WAS REPORTED ON THE SKIN BEYOND THE AREA. THE SKIN PROTECTANT WAS APPLIED TO THE BUTTOCKS FOR SEVERE REFRACTORY DIAPER DERMATITIS DUE TO LIQUID STOOLS FROM CHEMOTHERAPY. THE PRODUCT STUCK TO THE DIAPER AND WAS REMOVED WITHOUT ADHESIVE REMOVER. THE SKIN PROTECTANT WAS ON THE SKIN FOR TWO WEEKS, WHERE IT WAS REPORTED AS "CAKED ON" BY NURSES WHO DID NOT FOLLOW THE APPLICATION INSTRUCTIONS. THE SKIN WAS CLEANSED WITH A WOUND SOLUTION PRODUCT PRIOR TO APPLICATION OF 3M¿ CAVILON¿ ADVANCED SKIN PROTECTANT. NO MEDICAL TREATMENT WAS REQUIRED FOR THE SYMPTOMS.

  Patient problems: Skin Inflammation/ Irritation; Skin Tears

  MAUDE report 17227791 ↗
• InjuryApr 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED FROM (B)(6): ANAPHYLAXIS WAS REPORTED FOR A PATIENT WHO WAS TAKEN TO THE HOSPITAL BY AMBULANCE WHILE USING 3M CAVILON ADVANCED SKIN PROTECTANT 5050G. DETAIL REGARD THE SYMPTOMS EXPERIENCED WAS NOT PROVIDED, AND IT IS NOT KNOWN IF THERE WAS ANY MEDICAL INTERVENTION. THE PATIENT FULLY RECOVERED. NOTHING WAS REPORTED TO BE USED IN COMBINATION WITH CAVILON ADVANCED. THE LEG WAS CLEANED WITH NACL AND GAUZE. SILVERCEL/CARBOFLEX/FLIVASORB APPLIED TO THE LEG AND SECURED WITH CREPE BANDAGE, AFTER WHICH CAVILON ADVANCED SKIN PROTECTANT WAS APPLIED TO THE FOOT WITH A STOCKINETTE TO COVER.

  Patient problems: Anaphylactoid / Anaphylaxis

  MAUDE report 13981184 ↗
• InjuryApr 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HIVES WITH ITCHINESS WERE REPORTED THAT APPEARED APPLICATION OF 3M CAVILON ADVANCED SKIN PROTECTANT TO THE GLUTEAL CLEFT AT THE SITE WHERE A PRIOR SURGERY HAD BEEN PERFORMED FOR A PILONIDAL CYST. AN ANTISEPTIC SKIN CLEANSER WAS USED WHILE SHOWERING AND CAVILON ADVANCED SKIN PROTECTANT WAS THEN APPLIED. A NON-3M BRAND BARRIER WIPE WAS USED ONE DAY PRIOR. HIVES APPEARED THREE DAYS LATER; HYDROCORTISONE CREAM WAS APPLIED, AND ORAL DIPHENHYDRAMINE WAS TAKEN. AN URGENT CARE VISIT OCCURRED THREE DAYS LATER, WHERE ORAL PREDNISONE WAS PRESCRIBED FOR FIVE DAYS AND THE SYMPTOMS RESOLVED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 11681973 ↗
• InjuryDec 5, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A FLAMMABILITY EVENT WAS REPORTED AFTER APPLICATION OF 3M CAVILON ADVANCED SKIN PROTECTANT THAT WAS APPLIED IN PREPARATION FOR APPLICATION OF A WOUND VAC IN THE OPERATING ROOM DURING A CARDIAC SURGERY. A CAUTERY DEVICE WAS USED TO CAUTERIZE A SMALL BLOOD VESSEL, WHICH RESULTED IN A SMALL FLASH FLAME AND FIRST DEGREE BURN WITH ERYTHEMA ON THE CHEST AT THE INCISION SITE. MINOR TREATMENT WAS REPORTED AND THE BURN HEALED WELL. AN IN-SERVICE WAS CONDUCTED FOR OPERATING ROOM STAFF BY 3M AFTER THE INCIDENT OCCURRED. THE PRODUCT IFU CONTAINS WARNINGS THAT 3M CAVILON ADVANCED SKIN PROTECTANT IS HIGHLY FLAMMABLE UNTIL IT HAS COMPLETELY DRIED ON THE SKIN AND SHOULD ONLY BE APPLIED WHEN NO IGNITION SOURCES OR HEAT-PRODUCING DEVICES ARE IN USE.

  Patient problems: Burn(s); Erythema; Superficial (First Degree) Burn

  MAUDE report 10950616 ↗