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

Model Number	2228
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033)
Date of Event	04/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1, a4-a6: not provided.E1: initial reporter: address was 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 device labeling shall be reviewed for important contraindications, warnings, and cautions.
Event or Problem Description
A 41-year-old female allegedly experienced a localized allergic reaction with a redness, rash, and an itching sensation approximately five hours post application of the 3m¿ foam monitoring electrode 2228 lot (b)(6) 2024 la.The electrodes were subsequently removed, and a topical medicine was applied, type not provided.No additional information is available.

• 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: 17091523
• Report Number: 2110898-2023-00049
• Device Sequence Number: 6070228
• 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): 06/08/2023

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: 03/31/2024
• Device Model Number: 2228
• Device Catalogue Number: 2228
• Device Lot Number: 2024-04 LA
• 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: 05/09/2023
• Initial Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2022
• 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: 41 YR
• Patient Sex: Female