MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ CAVILON¿ ADVANCED SKIN PROTECTANT; BANDAGE, LIQUID

Model Number	N/A
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Skin Tears (2516); Skin Inflammation/ Irritation (4545)
Date of Event	05/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
A1, a5-a6, e3: information was not provided.H10: product was not returned for analysis.A trend analysis was completed with no issues identified.Based on provided information, it was reported that the product was "caked on" by nurses who did not follow the application instructions.It is unclear if medical conditions or use of other skin wound cleanser could have also contributed to the event.Proper application of 3m cavilon advanced skin protectant is important to prevent these types of adverse events.Excerpts from the instructions for use for 3m cavilon advanced skin protectant include the following: precautions: the product can increase the adhesion of some adhesive products (e.G.Tape), particularly in the first few days of use.When removing an adhesive product, it is important to exercise care and follow the directions for use.Directions for use: when used under adhesive tapes, dressings, or devices, allow the product to dry for approximately 1 minute before covering with adhesive products.Refer to precaution statement # 3.Cleanse affected area as needed.Cavilon advanced skin protectant is waterproof and is not removed by cleansing.· reapply one to three times per week.Frequent application may result in buildup of the product.· the film will wear off the skin and does not require removal.If removal is desired, the film should be removed with an adhesive remover containing hexamethyldisiloxane (hmds).· use an adhesive remover containing hmds to remove an adhesive product that has been placed over the film.This is especially important for patients with fragile skin.

• Brand Name: 3M¿ CAVILON¿ ADVANCED SKIN PROTECTANT
• Common Device Name: BANDAGE, LIQUID
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M COLUMBIA; 5400 paris road; columbia MO 65202
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144-1000 ; 6514612670
• MDR Report Key: 17227791
• Report Number: 2110898-2023-00061
• Device Sequence Number: 7090958
• Product Code: KMF
• UDI-Device Identifier: 50707387773361
• UDI-Public: 50707387773361
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/29/2023

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 5050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2023
• Initial Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: CHEMOTHERAPY AGENT(S)- UNSPECIFIED; VASHE® WOUND SOLUTION
• Outcome Attributed to Adverse Event: Other
• Patient Age: 8 MO
• Patient Sex: Female
• Patient Weight: 9 KG