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

Model Number	2570-5
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Scar Tissue (2060)
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported a patient underwent treatment and the 3m¿ red dot¿ monitoring electrode with foam tape and sticky gel, 2570-5 was placed for cardiac monitoring for approximately one month.The patient subsequently experienced scarring that has reportedly not subsided after a few days.
Additional Manufacturer Narrative
B3: date of event: not provided.D4: lot number & expiration date: not available.H4: manufacture date: not available.H10: product sample was not returned to 3m for analysis.Without a sample available, it is not possible to evaluate the sample for any defects or perform any tests to determine if the plate met specification.3m¿ cannot determine the exact root cause of the alleged injury or whether the 3m¿ red dot¿ monitoring electrode with foam tape and sticky gel was the root cause.The instructions for use states, 3m¿ red dot¿ monitoring electrode with foam tape and sticky gel 2570 series are disposable, intended for single use, and have been tested for up to 5 days wear.

• 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 55144-1000 ; 6514612670
• MDR Report Key: 16887287
• Report Number: 2110898-2023-00041
• Device Sequence Number: 6162980
• Product Code: DRX
• UDI-Device Identifier: 10707387463356
• UDI-Public: 10707387463356
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2023

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 Model Number: 2570-5
• Device Catalogue Number: 2570-5
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Disability
• Patient Sex: Unknown