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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Scarring (2061); Skin Irritation (2076)
Date of Event	06/20/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: ECG ELECTRODE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 9182944
• Report Number: 2110898-2019-00116
• Device Sequence Number: 3642723
• Product Code: DRX
• UDI-Device Identifier: 10707387507845
• UDI-Public: 10707387507845
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2019

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention