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

Model Number	5051G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	01/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample was not returned for analysis; therefore, the cause of the reaction could not be determined.The patient's medical history includes skin sensitivities and a history of allergy to tegaderm.The patient underwent dc chemotherapy for 4 cycles, with the fourth cycle completed five days prior to application of 3m¿ cavilon¿ advanced skin protectant.No other complaints of sensitivity/allergies have been received for lot 4205a.Solventum will continue to monitor.
Event or Problem Description
Skin rashes with redness, itchiness, swelling, and blisters developed at the application site of 3m¿ cavilon¿ advanced skin protectant.No skin preparations or other wound care products were applied prior to application.Skin redness and itchiness began two days later; the symptoms progressed into a skin rash with swelling and blisters due to a possible allergic reaction, described as a diffused pattern, about 30cm in length, extending from the axillary region around the anterior torso.Two discrete rashes, each measuring 3x3 cm, were located on both upper arms.The rash began to subside one week later and an unspecified topical steroid and piriton allergy tablets were prescribed.The rash still existed days later but subsided.Use was discontinued when the symptoms appeared.

• Brand Name: 3M¿ CAVILON¿ ADVANCED SKIN PROTECTANT
• Common Device Name: BANDAGE, LIQUID
• Manufacturer (Section D): 3M COMPANY; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M COLUMBIA; 5400 paris road; columbia MO 65202
• Manufacturer Contact: yvonne mcmann ; 6203 farinon drive; san antonio, TX 78249 ; 2103743188
• MDR Report Key: 21633165
• Report Number: 2110898-2025-00018
• Device Sequence Number: 20703130
• Product Code: KMF
• UDI-Device Identifier: 10707387810679
• UDI-Public: 01107073878106791726080511240805104205A
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K153571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2025

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 Expiration Date: 08/05/2026
• Device Model Number: 5051G
• Device Catalogue Number: 5051G
• Device Lot Number: 4205A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2024
• 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 Sex: Unknown