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

Catalog Number 2660

Device Problem Human-Device Interface Problem (2949)

Patient Problems Burn(s) (1757); Erythema (1840); Pain (1994); Peeling (1999); Scar Tissue (2060); Skin Inflammation/ Irritation (4545)

Event Date 10/31/2023

Event Type  Injury  

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 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.

• Brand Name: 3M¿ RED DOT¿ REPOSITIONABLE MONITORING ELECTRODES
• Type of Device: 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
• MDR Text Key: 333658411
• Report Number: 2110898-2024-00002
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 10707387507838
• UDI-Public: 10707387507838
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2660
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 59 KG