MAUDE Adverse Event Report: 3M CANADA COMPANY 3M¿ RED DOT¿ REPOSITIONABLE MONITORING ELECTRODE; ELECTROCARDIOGRAPHIC ELECTRODE

Catalog Number	2670-5
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Ecchymosis (1818); Hemorrhage/Blood Loss/Bleeding (1888); Skin Tears (2516)
Date of Event	04/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A 73-year-old male weighing 290 lbs allegedly experienced an approximately 1" skin tear on left forearm with ecchymosis and bleeding 45 minutes post application of the 3m¿ red dot¿ soft cloth monitoring electrode, 2670-5, lot 202408te, that required medical treatment described as "cleaned and dressed" in order to treat a minor injury, and not to prevent a serious injury.The patient was discharged home.
Additional Manufacturer Narrative
H10: 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 definitively determine the root cause.3m will continue to monitor.The instructions for use states, 3m¿ red dot¿ repositionable monitoring electrodes are disposable and may be safely worn up to 3 days which may vary depending on skin condition and environmental factors.The 2670 electrode has adhesive that is more aggressive than the 2660 and should be used if the level of adhesion of the 2660 is too low for a particular patient or clinical application.To minimize skin trauma during electrode removal, pull up slowly and gently from the tab or the edge of the electrode.

• Brand Name: 3M¿ RED DOT¿ REPOSITIONABLE MONITORING ELECTRODE
• Common Device Name: ELECTROCARDIOGRAPHIC ELECTRODE
• 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: 17662954
• Report Number: 2110898-2023-00081
• Device Sequence Number: 7087688
• Product Code: DRX
• UDI-Device Identifier: 10707387789227
• UDI-Public: 10707387789227
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/31/2023

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: 08/27/2024
• Device Catalogue Number: 2670-5
• Device Lot Number: 202408TE
• 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: 08/02/2023
• Initial Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2022
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 132 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White