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

Model Number	2660-3
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Erythema (1840); Skin Tears (2516); Skin Inflammation/ Irritation (4545)
Date of Event	04/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: product sample was not returned to 3m for analysis.Without a sample available, it is not possible to evaluate the sample for any defects or perform any tests to determine if the electrode met specification.3m¿ cannot determine the exact root cause of the alleged injury or whether the 3m¿ red dot¿ electrode was the root cause.The device labeling shall be reviewed for important contraindications, warnings, and cautions.
Event or Problem Description
Report received via medwatch 4900240000-2023-8070: a hospital reported a female patient allegedly experienced skin removal, irritation with erythema and a rash with the use of the 3m¿ red dot¿ electrode.No medical intervention was reported.

• Brand Name: 3M¿ RED DOT¿ ELECTRODE
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• 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: 16988958
• Report Number: 2110898-2023-00044
• Device Sequence Number: 6853209
• Product Code: DRX
• UDI-Device Identifier: 10707387789098
• UDI-Public: 10707387789098
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2023

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: 2660-3
• Device Catalogue Number: 2660-3
• 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: 04/27/2023
• Initial Report FDA Received Date: 05/23/2023
• 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
• Patient Age: 2 MO
• Patient Sex: Female
• Patient Weight: 2 KG