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

Model Number	N/A
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Erythema (1840); Rash (2033); Blister (4537); Skin Burning Sensation (4540); Swelling/ Edema (4577)
Date of Event	08/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
The product has not been returned for analysis.Previous history of skin sensitivities, dermatological pathologies, allergies and skin reactions to other dressings and adhesives.

• 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: 15350656
• Report Number: 2110898-2022-00071
• Device Sequence Number: 5825907
• Product Code: KMF
• UDI-Device Identifier: 30707387509768
• UDI-Public: 30707387509768
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/02/2022

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 Model Number: N/A
• Device Catalogue Number: 3345
• Device Lot Number: 202502CA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White