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

Model Number	2560
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Erythema (1840); Itching Sensation (1943); Pain (1994); Rash (2033); Blister (4537); Skin Inflammation/ Irritation (4545)
Date of Event	11/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A female patient allegedly experienced a right ankle skin reaction with erythema, soreness to the touch, blistering, with post removal itchy sensation with the use of 3m¿ red dot¿ monitoring electrode with foam tape and sticky gel, 2560.The electrodes were placed upon hospital admission on (b)(6) 2022.Within a two-week period, the patient reportedly had "many" electrodes applied at various locations on the body that were changed while the ankle electrode remained in place and was not changed at any point throughout the 2-week hospitalization.On (b)(6) 2022, the patient was discharged from the hospital with the ankle electrode reportedly still attached and it was noted that "it may have been left on accidentally." on (b)(6) 2023, the patient reportedly removed the electrode at home and allegedly observed redness at the ankle electrode site.On (b)(6) 2022, a dermatologist observed the patient and advised to apply advantan® corticosteroid cream which reportedly did not work, as the rash was allegedly spreading.The patient was experiencing redness with an itching sensation and no skin stripping.On (b)(6) 2023, it was reported that tree oil was applied twice to relieve the itching.On (b)(6) 2023, the area was inflamed due to the tree oil, and it was thought the oil "burnt" the pustules.On (b)(6) 2023, there was no broken skin, and the area was tender to touch.The dermatologist suggested applying vaseline and saltwater wash which eased the itching sensation and the resolved the pustules.The customer noted the product was used for a longer than specified time recommended in the instructions for use, and indicated there were no apparent blisters, however it was mentioned once in conversation therefore it is marked as present.It was reported the alleged rash and blisters/pustules did not spread.It was reported the redness and itching were "distracting" and the dermatologist's recommendation that the customer use the advantan® corticosteroid cream for patient comfort.No medical interventions were reportedly required.
Additional Manufacturer Narrative
Patient specifics are unknown.Common device: lot and expiration dates are unknown.Device manufacture date is unknown.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.The electrode was worn beyond the stated time limit in the instructions for use.The instructions for use states, 3m¿ red dot¿ monitoring electrode with foam tape and sticky gel 2560 are disposable, intended for single use, and has been tested for up to 5 days wear.

• 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: 16363229
• Report Number: 2110898-2023-00021
• Device Sequence Number: 6926821
• Product Code: DRX
• UDI-Device Identifier: 10707387463257
• UDI-Public: 10707387463257
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2023

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: 2560
• Device Catalogue Number: 2560
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 02/13/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ADVANTAN® CORTICOSTEROID CREAM
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female