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

Model Number	5050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fungal Infection (2419)
Date of Event	08/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer used 3m¿ cavilon¿ advanced skin protectant with her ostomy bag and experienced itchy and bright pink skin.Additional information was received from the customer on (b)(6) 2025 indicating a yeast infection developed and treatment was initiated with topical nystatin.Changes were made to the ostomy wafer application process with the help of a wound, ostomy and continence nurse (wocn), and the symptoms improved.
Additional Manufacturer Narrative
The alleged event was determined to be a serious injury based on the additional information received (b)(6) 2025 indicating a fungal infection occurred requiring medication.The device has not been returned to solventum for analysis.A lot number was provided; no other complaints have been received for this lot.The root cause of the symptoms cannot be determined.Solventum will continue to monitor.

• 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 Contact: yvonne mcmann ; 6203 farinon drive; san antonio, TX 78249 ; 2103743188
• MDR Report Key: 23095829
• Report Number: 2110898-2025-00061
• Device Sequence Number: 15828542
• Product Code: KMF
• UDI-Device Identifier: 10707387810693
• UDI-Public: 01107073878106931727022411250224100011871704
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2025

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: Lay User/Patient
• Device Model Number: 5050
• Device Catalogue Number: 5050
• Device Lot Number: 0011871704
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2025
• 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: Female