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

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 02/10/2019

Event Type  Injury  

Manufacturer Narrative

Information was not provided.Based on the information provided, the reported reaction may be an individual patient sensitivity or potential allergy.End of report.

Event Description

A consumer reported four 2255-50 3m¿ red dot¿ soft cloth monitoring electrodes were applied for cardiac monitoring.The consumer allegedly experienced a bright red raised rash, extreme itching and oozing three days after application of the electrodes.The electrodes and cardiac monitoring were discontinued.The reaction started to spread outside the area where the electrodes were applied.The consumer reportedly consulted a dermatologist and was treated with a topical rx ointment.

• 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: 8370845
• MDR Text Key: 137172400
• Report Number: 2110898-2019-00029
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 10707387569584
• UDI-Public: 10707387569584
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/28/2020
• Device Model Number: N/A
• Device Catalogue Number: 2255-50
• Device Lot Number: 2020-11 HH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• 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): Required Intervention
• Patient Age: 58 YR