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

Model Number	2560
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient had an electrocardiogram (ecg or ekg) performed in the emergency department (ed).According to patient, when the nurse removed the electrode the adhesive removed skin.The ekg tech also performed an ekg, and could not remove one of the electrodes even with the help of an alcohol pad.The patient asked her to leave it and she would remove it in the shower.The ekg techs believe the adhesive on the multi-packs of ekg electrodes is now much more sticky than before.

• Brand Name: 3M¿ RED DOT¿
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): 3M COMPANY; 3m center, 2510 conway avenue; bldg. 275-5w-06; saint paul MN 55144
• MDR Report Key: 21102014
• Report Number: 21102014
• Device Sequence Number: 8657349
• Product Code: DRX
• UDI-Device Identifier: 10707387789302
• UDI-Public: (01)10707387789302
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/10/2024
• Report Date (Section F): 12/10/2024

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2025
• 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: 67 YR
• Patient Sex: Female
• Date Report Sent to FDA: 12/10/2024