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

Catalog Number 2670-5

Device Problem Human-Device Interface Problem (2949)

Patient Problems Ecchymosis (1818); Skin Tears (2516)

Event Date 02/07/2023

Event Type  Injury  

Event Description

A 82-year-old male weighing 160 lbs allegedly experienced localized bruising on the left forearm and right wrist with a 1.5 cm left forearm skin tear 30 minutes post application of the 3m¿ red dot¿ repositionable 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.

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
• Type of Device: 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: 17661471
• MDR Text Key: 322392516
• Report Number: 2110898-2023-00080
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 10707387789227
• UDI-Public: 10707387789227
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2670-5
• Device Lot Number: 202408TE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White