MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ CAVILON¿ NO STING BARRIER FILM

Model Number	N/A
Health Effect - Clinical Codes	Full thickness (Third Degree) Burn (2696); Blister (4537); Skin Inflammation/ Irritation (4545)
Date of Event	01/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information not provided.The product was not returned for analysis.A lot number was provided.The product instructions for use contains a precautionary statement that if redness or other signs of irritation appear, or if redness or signs of irritation persist, to consult a physician.End of report.
Event or Problem Description
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.
Additional Manufacturer Narrative
Information not provided.The product was not returned for analysis.A lot number was provided.The product instructions for use contains a precautionary statement that if redness or other signs of irritation appear, or if redness or signs of irritation persist, to consult a physician.End of report.
Event or Problem Description
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.

• Brand Name: 3M¿ CAVILON¿ NO STING BARRIER FILM
• Common Device Name: 3M¿ CAVILON¿ NO STING BARRIER FILM
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): APHENA PHARMA SOLUTIONS; 7978 industrial park road; easton MD 21601
• Manufacturer Contact: dianne gibbs ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144-1000 ; 6517379117
• MDR Report Key: 13459968
• Report Number: 2110898-2022-00008
• Device Sequence Number: 3895731
• Product Code: KMF
• UDI-Device Identifier: 30707387766321
• UDI-Public: 30707387766321
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K955103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/12/2024
• Device Model Number: N/A
• Device Catalogue Number: 3342
• Device Lot Number: 2024-04 CB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SAFE N SIMPLE¿ ADHESIVE REMOVER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male