MAUDE Adverse Event Report: 3M CANADA COMPANY 3M¿ RED DOT¿ MONITORING ELECTRODE WITH FOAM TAPE AND STICKY GEL; ECG ELECTRODE

Model Number	2570
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Event or Problem Description
A 23-year-old female allegedly experienced an anaphylactic reaction with the use of 3m¿ red dot¿ monitoring electrode with foam tape and sticky gel, 2570 that was subsequently described as a chest urticarial skin reaction.The patient's skin was initially prepped with fastaid® pre-injection swab (70% isopropanol), three electrodes were applied to the chest area that were held in position with an o-fix sticker.The following day, an urticarial skin reaction was observed that was reportedly treated with antihistamines.Upon subsequent representation, tongue swelling was identified.The patient was treated for angioedema with antihistamines, steroids, intramuscular adrenaline and was transferred to the icu [intensive care unit].The patient reportedly had a "good" recovery.On day three, the patient was transferred to the ward and was subsequently discharged home on day five.
Additional Manufacturer Narrative
Initial reporter occupation: it is unknown if the reporter is a health professional a sample was not returned.Without a sample, it is not possible to perform any tests to determine if the device met specifications.Without additional information, it is not possible to determine the root cause of the alleged injury or whether an electrode was the root cause.

• Brand Name: 3M¿ RED DOT¿ MONITORING ELECTRODE WITH FOAM TAPE AND STICKY GEL
• Common Device Name: ECG ELECTRODE
• Manufacturer (Section D): 3M CANADA COMPANY; 400 route 100; morden, manitoba R6M 1 Z9; CA R6M 1Z9
• Manufacturer (Section G): 3M CANADA COMPANY; 400 route 100; morden, manitoba R6M 1 Z9; CA R6M 1Z9
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144-1000 ; 6514612670
• MDR Report Key: 16279496
• Report Number: 2110898-2023-00018
• Device Sequence Number: 6871050
• Product Code: DRX
• UDI-Device Identifier: 10707387463271
• UDI-Public: 10707387463271
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K970796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/01/2023

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: Health Professional
• Device Model Number: 2570
• Device Catalogue Number: 2570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown