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 Interaction Problem (4001)
Health Effect - Clinical Codes	Blister (4537); Contact Dermatitis (4546)
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer alleged a patient experienced contact dermatitis with blistering that required topical triamcinolone cream treatment and a delay in surgery with the use of the 3m¿ red dot¿ monitoring electrode with foam tape and sticky gel, 2560.
Additional Manufacturer Narrative
B3: date not provided.D4: lot # & expiration date: unknown.D9: device not returned to manufacturer to date.E2 - e3: it is unknown if the reporter is a health professional.H4: manufacture date: unknown.H10: an evaluation of the electrode is not possible as a sample from the customer was not received.It is unknown how long the device was in place.The instructions for use states, 3m¿ red dot¿ monitoring electrode with foam tape and sticky gel 2560 are disposable, intended for single use, and has 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: 16694116
• Report Number: 2110898-2023-00036
• Device Sequence Number: 14980478
• Product Code: DRX
• UDI-Device Identifier: 10707387463257
• UDI-Public: 10707387463257
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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 Model Number: 2560
• Device Catalogue Number: 2560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 04/06/2023
• 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: Other; Required Intervention
• Patient Sex: Unknown