MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ RED DOT¿ NEONATAL, PRE-WIRED, RADIOLUCENT MONITORING ELECTRODE WITH CLEAR TA; ELECTROCARDIOGRAPHIC ELECTRODE, SINGLE-USE

Model Number	2269T
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Erythema (1840); Skin Tears (2516); Blister (4537); Skin Maceration (4841)
Date of Event	11/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.This is an on-going low-level issue which was identified through customer complaints.Multiple studies are regularly conducted that have demonstrated appropriate device biocompatibility and safety performance criteria when the device is used appropriately on humans.Known failure modes include allergies and sensitivities to adhesives or other components and incorrect use of product.
Event or Problem Description
A 5-week-old male experienced left upper chest erythema, skin tears, maceration, and a 4cm x 4cm blister in less than 24-hours post application of 3m¿ red dot¿ neonatal, pre-wired, radiolucent monitoring electrode with clear tape, 2269t lot: 202407ab.Medical treatment was reportedly required described as wound care that included treatment with 3m¿ cavilon¿ no sting barrier film, and the symptoms subsequently resolved after three days.

• Brand Name: 3M¿ RED DOT¿ NEONATAL, PRE-WIRED, RADIOLUCENT MONITORING ELECTRODE WITH CLEAR TA
• Common Device Name: ELECTROCARDIOGRAPHIC ELECTRODE, SINGLE-USE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• 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: 15912441
• Report Number: 2110898-2022-00122
• Device Sequence Number: 5486369
• Product Code: DRX
• UDI-Device Identifier: 30707387140923
• UDI-Public: 10707387140929
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2022

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: 07/27/2024
• Device Model Number: 2269T
• Device Catalogue Number: 2269T
• Device Lot Number: 202407AB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 12/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2022
• 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: Other
• Patient Age: 5 WK
• Patient Sex: Male
• Patient Weight: 3 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White