MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ RED DOT¿ 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	Skin Irritation (2076); Reaction (2414)
Date of Event	07/18/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: ECG ELECTRODE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 7758337
• Report Number: 2110898-2018-00080
• Device Sequence Number: 19152696
• Product Code: DRX
• UDI-Device Identifier: 10707387569584
• UDI-Public: 10707387569584
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2018

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 Model Number: N/A
• Device Catalogue Number: 2255-50
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 08/07/2018
• 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: Required Intervention
• Patient Age: 48 YR
• Patient Weight: 141