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

Model Number	2560
Health Effect - Clinical Codes	Pain (1994); Skin Inflammation/ Irritation (4545)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Recently there has been a change with the level of adhesive on the red dot stickers (2560) used to perform electrocardiograms (ekgs).The stickers are much more stickier, there is less gel in the center, and we've had trouble getting them off of patients resulting in more pain for the patient.This morning i did an ekg on a patient ¿ i went to remove the sticker from the left arm however, it would not budge because of her thin skin and the amount of adhesive.I had to use detachol to remove the sticker which took me about two minutes to do because i didn't want to tear her skin.Its also causing irritation, more pain, and we are having more trouble getting the machine to read the rhythms.

• 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: 20795794
• Report Number: 20795794
• Device Sequence Number: 15406092
• 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): 11/26/2024
• Report Date (Section F): 11/26/2024

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
• Device Lot Number: 202610CQ
• 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: 11/27/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2024
• 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: 2 MO
• Patient Sex: Female
• Date Report Sent to FDA: 11/26/2024