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

Model Number	2360
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	04/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A hospital reported a patient allegedly experienced a skin tear post removal of the 3m¿ red dot¿ resting ekg electrode, 2360 lot 2023-10 nm.The 3m¿ red dot¿ resting ekg electrode reportedly contained "an excessive amount of adhesive." no medical intervention was reported.
Additional Manufacturer Narrative
A1-a6: patient specifics are unknown.E2 - e3: it is unknown if the reporter is a health professional.G2: it is unknown if the report source is a health professional.A 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 the 3m¿ red dot¿ resting ekg electrode was the root cause.The device labeling shall be reviewed for important contraindications, warnings, and cautions.

• Brand Name: 3M¿ RED DOT¿ RESTING EKG 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: 16864287
• Report Number: 2110898-2023-00040
• Device Sequence Number: 12284430
• Product Code: DRX
• UDI-Device Identifier: 00707387472825
• UDI-Public: 00707387472825
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K974445
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2023

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 Expiration Date: 10/27/2023
• Device Model Number: 2360
• Device Catalogue Number: 2360
• Device Lot Number: 2023-10 NM
• 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: 04/07/2023
• Initial Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2021
• 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 Sex: Unknown