MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ RED DOT¿ SOFT CLOTH MONITORING ELECTRODES; ECG ELECTRODE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Scarring (2061); Skin Irritation (2076)

Event Date 06/20/2018

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided.No samples were returned for evaluation.Cause of reported injury could not be determined.The consumer associated with this incident reported the event to the fda via medwatch mw5078271.A device history review was completed on the reported lot # and did not reveal any quality issues with the product.

Event Description

A distributor reported that a patient alleged skin irritation, described as a blister/burn in two areas of the chest, that began approximately one week after monitoring using 3m¿ red dot¿ ecg repositionable soft cloth monitoring electrodes, 2660-5.The patient informed the distributor of the alleged symptoms after approximately 20 days of monitoring and had disconnected the monitoring system.Upon follow-up by the distributor one month later, the patient reported that the skin was pink and peeling.The patient visited her cardiologist and no treatment was prescribed.A medwatch report was received by the distributor (mw5078271) that the patient had submitted to the fda which indicated that an area in the center of the chest looked to be a permanent scar.

• Brand Name: 3M¿ RED DOT¿ SOFT CLOTH MONITORING ELECTRODES
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M CANADA COMPANY; 400 route 100; morden, R6M 1 Z9; CA R6M 1Z9
• Manufacturer Contact: dianne gibbs ; 3m center, building 275-5w-06; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 9182944
• MDR Text Key: 162431964
• Report Number: 2110898-2019-00116
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 10707387507845
• UDI-Public: 10707387507845
• 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: consumer,distributor,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/22/2020
• Device Model Number: N/A
• Device Catalogue Number: 2660-5
• Device Lot Number: 2020 -04 FC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2018
• 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): Life Threatening; Required Intervention