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

Model Number 2570-5

Device Problem Use of Device Problem (1670)

Patient Problem Scar Tissue (2060)

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 314750255
• Report Number: 2110898-2023-00041
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 10707387463356
• UDI-Public: 10707387463356
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2570-5
• Device Catalogue Number: 2570-5
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability