MAUDE Adverse Event Report: 3M CANADA COMPANY 3M¿ RED DOT¿ MONITORING ELECTRODE WITH FOAM TAPE AND STICKY GEL; ECG ELECTRODE

Model Number	2560
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	02/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient specifics are unknown.Device not returned to manufacturer to date.An evaluation of the electrode is not possible as a sample from the customer was not received.The instructions for use states, 3m¿ red dot¿ monitoring electrode with foam tape and sticky gel 2560 are disposable and is intended for single use.For electrode removal, the electrode should be pulled slowly and gently from the edge of the electrode, while folding the electrode back on itself and supporting the skin underneath.
Event or Problem Description
Report received from the fda via medwatch form mw5115239.A nurse reported a patient allegedly experienced a 1-inch x 0.5 inch left upper chest skin tear with erythema, and bleeding post removal of 3m¿ red dot¿ monitoring electrode with foam tape and sticky gel 2560, lot 2024-11 cy that reportedly required medical treatment described as "first aid." on postoperative day 1, the skin tear appeared to be healing with scant serosanguinous drainage and scabbing present along edges of the skin tear.No purulence or active bleeding was observed.The patient reportedly has a history of skin sensitivities due to "thin skin." no additional information is available.

• Brand Name: 3M¿ RED DOT¿ MONITORING ELECTRODE WITH FOAM TAPE AND STICKY GEL
• Common Device Name: ECG ELECTRODE
• Manufacturer (Section D): 3M CANADA COMPANY; 400 route 100; morden, manitoba R6M 1 Z9; CA R6M 1Z9
• Manufacturer (Section G): 3M CANADA COMPANY; 400 route 100; morden, manitoba R6M 1 Z9; CA R6M 1Z9
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6514612670
• MDR Report Key: 16690433
• Report Number: 2110898-2023-00031
• Device Sequence Number: 5930969
• Product Code: DRX
• UDI-Device Identifier: 10707387463257
• UDI-Public: 10707387463257
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K970796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/06/2023

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 Expiration Date: 11/18/2024
• Device Model Number: 2560
• Device Catalogue Number: 2560
• Device Lot Number: 2024-11 CY
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2022
• 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: Other
• Patient Sex: Unknown