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	03/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A hospital reported a patient allegedly experienced skin damage with the use of the 3m¿ red dot¿ monitoring electrode with foam tape and sticky gel, 2560.One week post application of the 3m¿ red dot¿ monitoring electrode with foam tape and sticky gel, the patient removed the electrodes and reportedly observed a 2cm x 3cm area of skin damage with no bleeding.The area improved post disinfection, and administration of medication, type not provided.No additional information was provided.
Additional Manufacturer Narrative
A1-a6: patient specifics: not provided.D4: lot number and expiration date: unknown.It is unknown if the initial reporter is a health professional.It is unknown if the report source is a health professional.Manufacture date: unknown.Product sample was not returned to 3m for analysis.Without a sample, it is not possible to perform any tests to determine if the device met specifications.Without additional information, it is not possible to determine the root cause of the alleged injury or whether an electrode was the root cause.The electrode was worn beyond the stated time limit in the instructions for use.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.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.

• 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: 16818219
• Report Number: 2110898-2023-00037
• Device Sequence Number: 7132161
• Product Code: DRX
• UDI-Device Identifier: 10707387463257
• UDI-Public: 10707387463257
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2023

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: 03/28/2023
• Initial Report FDA Received Date: 04/26/2023
• 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: Required Intervention
• Patient Sex: Unknown