MAUDE Adverse Event Report: 3M CANADA COMPANY 3M¿ ECG MONITORING ELECTRODES, FOAM DIAPHORETIC; ELECTROCARDIOGRAPHIC ELECTRODE

Catalog Number	2228
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Erythema (1840); Rash (2033); Swelling/ Edema (4577)
Date of Event	06/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1 & a4-a6: not provided.E1 reporter: not provided.E2-e3: it is unknown if the reporter was a health professional.-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, 3m¿ ecg monitoring electrodes, foam diaphoretic, 2228 are disposable, intended for single use, and has been tested for up to 3 days wear.For proper skin management and to minimize skin irritation: avoid placing an electrode on an irritated skin site.Do not abrade a skin site more than one time.Avoid removing electrodes frequently and/or reapplying to the same skin site.Avoid placing electrodes on skin still wet from an alcohol wipe (dry thoroughly).Assess electrode sites periodically.
Event or Problem Description
A 6-month-old male patient was admitted to hospital ecg monitoring was performed with 3m red dot electrodes, 2228, lot 2025-01 li.Mid-morning the same day, a 2x2cm skin rash higher than the skin surface with localized redness and swelling appeared at the electrode application site.The electrodes were replaced/applied to a different site and erythromycin ointment was applied on the affected area.

• Brand Name: 3M¿ ECG MONITORING ELECTRODES, FOAM DIAPHORETIC
• 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; 2510 conway ave; st. paul, MN 55144-1000 ; 6514612670
• MDR Report Key: 17670910
• Report Number: 2110898-2023-00083
• Device Sequence Number: 12343366
• Product Code: DRX
• UDI-Device Identifier: 10707387789524
• UDI-Public: 10707387789524
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2023

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 Expiration Date: 01/10/2025
• Device Catalogue Number: 2228
• Device Lot Number: 2025-01 LI
• 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: 08/08/2023
• Initial Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2023
• 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
• Patient Age: 6 MO
• Patient Sex: Male