MAUDE Adverse Event Report: 3M CANADA COMPANY 3M¿ RED DOT¿ REPOSITIONABLE MONITORING ELECTRODES; ELECTROCARDIOGRAPHIC ELECTRODE

Catalog Number	2660
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Burn(s) (1757); Erythema (1840); Pain (1994); Peeling (1999); Scar Tissue (2060); Skin Inflammation/ Irritation (4545)
Date of Event	10/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1, a5-a6: not provided.H10: product sample was not returned to 3m for analysis.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 definitively determine the root cause.The instructions for use states, the 3m¿ red dot¿ repositionable monitoring electrodes are radiolucent with a silver/silver-chloride sensing element and may be safely worn up to 3 days.-for proper skin management and to minimize skin irritation: o avoid placing an electrode on an irritated skin site.O do not abrade a skin site more than one time.O avoid placing electrodes on skin still wet from an alcohol wipe (dry thoroughly) o assess electrode sites periodically.-during surgical procedures, place ecg electrodes as far as possible from the electrosurgical site to minimize rf current flow through the electrode site.Otherwise burns could result at the ecg electrode site.
Event or Problem Description
A patient allegedly experienced burns, scarring, skin discoloration, irritation, pain, erythema, and red peeling skin with the use of the 3m¿ red dot¿ repositionable monitoring electrodes.The patient had a holter monitor for 1 week starting on (b)(6) 2023.Four electrodes were applied to the chest and were changed every other day.On (b)(6) 2023 the patient observed the symptoms and the patient's physician referred her to a dermatologist.On the same day, (b)(6) 2023, the dermatologist administered prescribed clobetasol prop 0.05% cream and steroid methylprednisolone 4 mg which reportedly helped the redness and the pain that had lasted for 2 weeks.The patient is also using aquaphor on the scars which are reportedly not going away.
Additional Manufacturer Narrative
An insufficient sample was returned with no lot identifier or packaging, therefore, appropriate testing and root cause analysis cannot be performed.

• Brand Name: 3M¿ RED DOT¿ REPOSITIONABLE MONITORING ELECTRODES
• Common Device Name: ELECTROCARDIOGRAPHIC 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; st. paul, MN 55144-1000 ; 6514612670
• MDR Report Key: 18576470
• Report Number: 2110898-2024-00002
• Device Sequence Number: 9163284
• Product Code: DRX
• UDI-Device Identifier: 10707387507838
• UDI-Public: 10707387507838
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2024

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 Catalogue Number: 2660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 05/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Disability
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 130 KG