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

Model Number N/A

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

Patient Problems Skin Irritation (2076); Reaction (2414)

Event Date 07/18/2018

Event Type  Injury  

Manufacturer Narrative

Without a lot number, the expiration date and manufacture date could not be determined.The cause of the reaction could not be determined.The reporter did not have a lot number or sample available for analysis.End of report.

Event Description

A consumer reported four 2255-50 3m¿ red dot¿ soft cloth monitoring electrodes were applied for a home cardiac monitoring test.The consumer reportedly experienced itching and burning shortly after application.She reportedly changed the electrodes daily.The reaction progressed to redness, rash and severe irritation where the electrodes had been applied.She discontinued use of the electrodes after 5 days due to the skin reaction.Otc cortisone cream, aloe vera, and menthol were initially applied for treatment.The reaction did not improve, and she started to experience a low-grade fever and chills.A dermatologist was consulted, and she was given a prescription for triamcinolone 0.1% ointment and oral cephalexin 500 mg.Two days following use of the medications, the consumer reported three of the areas were cleared up and the fourth area was improving.

• Brand Name: 3M¿ RED DOT¿ 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: 7758337
• MDR Text Key: 116290147
• Report Number: 2110898-2018-00080
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 2255-50
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 48 YR
• Patient Weight: 141