MAUDE Adverse Event Report: 3M COMPANY 3M¿ RED DOT¿; ELECTRODE, ELECTROCARDIOGRAPH

Model Number	2560
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
When removing electrodes, very hard to remove resulting in skin tear of patient.

• Brand Name: 3M¿ RED DOT¿
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): 3M COMPANY; 3m center, 2510 conway ave.; bldg. 275-5w-06; saint paul MN 55144
• MDR Report Key: 23756886
• Report Number: 23756886
• Device Sequence Number: 9993028
• Product Code: DRX
• UDI-Device Identifier: 10707387789302
• UDI-Public: (01)10707387789302(17)271002(10)202710CC
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/11/2025
• Report Date (Section F): 11/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2560
• Device Catalogue Number: 2560
• Device Lot Number: 202710CC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/09/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Date Report Sent to FDA: 11/11/2025