MAUDE Adverse Event Report: 3M COMPANY 3M CAVILON; BANDAGE, LIQUID

Model Number	3343K
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
No sting barrier film was dry.

• Brand Name: 3M CAVILON
• Common Device Name: BANDAGE, LIQUID
• Manufacturer (Section D): 3M COMPANY; 3m center; 2510 conway avenue bldg. 275-5; saint paul MN 55144
• MDR Report Key: 19518781
• Report Number: 19518781
• Device Sequence Number: 18227129
• Product Code: KMF
• UDI-Device Identifier: 00707387809584
• UDI-Public: (01)00707387809584(11)231024(17)261023(10)2310238
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/17/2024
• Report Date (Section F): 05/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3343K
• Device Catalogue Number: 3343K
• Device Lot Number: 2310238
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/17/2024