MAUDE Adverse Event Report: 3M COMPANY 3M¿ RED DOT¿ ECG MONITORING ELECTRODES; ELECTRODE, ELECTROCARDIOGRAPH

Model Number	2670-3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Caustic/Chemical Burns (2549)
Date of Event	06/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer presented to the hospital for dizziness due to potential heart issues and 3m¿ red dot¿ ecg monitoring electrodes, 2670-3 were allegedly applied for heart monitoring.Two days post electrode application, the patient allegedly experienced redness, pain, blistering, severe burns with scarring.The customer presented to urgent care the same day, was diagnosed with a 2cm x 2cm left upper chest erythematous chemical burn with blistering, and was discharged the same day with a treatment plan noted as application of silver sulfadiazine 1% external cream, twice a day for 10 days, 8 grams.
Additional Manufacturer Narrative
A product sample was not returned to 3m for analysis.Without a sample available, it is not possible to evaluate the sample for any defects or perform any tests to determine if the device met specification.3m¿ cannot determine the exact root cause of the alleged injury or whether an electrode was the root cause.

• Brand Name: 3M¿ RED DOT¿ ECG MONITORING ELECTRODES
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): 3M COMPANY; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M MORDEN; 400 rt. 100; morden,manitoba ; CA
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6514612670
• MDR Report Key: 18994902
• Report Number: 2110898-2024-00014
• Device Sequence Number: 20720537
• Product Code: DRX
• UDI-Device Identifier: 10707387789234
• UDI-Public: 10707387789234
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2024

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: 2670-3
• Device Catalogue Number: 2670-3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 03/28/2024
• 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: Required Intervention; Disability
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 103 KG