MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC UNIVERSAL ELECTRODE-PATCH; ELECTRODE - PATCH - UNIVERSAL 2 CHANNEL

Model Number	02-01609
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Burn(s) (1757); Hemorrhage/Blood Loss/Bleeding (1888); Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545)
Date of Event	02/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2025, that the patient has developed a rash from the mcot sensor - 3.0 and electrode - patch - universal 2 channels.The patient's mother indicated that he patient's skin is so irritated it is bleeding and hurting.The patient's mother consulted with the care team through mychart.The patient took breaks wearing the device when the mcot sensor - 3.0 was charging and would place ointment on the skin.On (b)(6) 2025, the patient's mother removed the mcot sensor - 3.0 due it getting so hot the patient could no longer wear it.Additional information was requested but could not be obtained.
Additional Manufacturer Narrative
It was reported that the patient had a reaction while using the lectrode: patch: universal 2 channel.The patient developed a bad rash.The electrode was unable to be inspected because it was not returned.Allegation should be considered confirmed as there are images of the patient's skin irritation and/or evidence the patient sought medical care to treat the skin irritation.The associated skin irritation is likely related to the patient reacting to the electrode adhesive and/or hydrogel.The following factors were identified as having contributed to the skin irritation: age extremes (infant 0-12 months, pediatric 1-18 years, elderly 65 and older).Medical adhesive related skin injury (marsi) is likely related to a biocompatibility hazard manifesting at the electrode's interface with the patient's skin.Patient reactions, such as skin irritation, resulting from biocompatibility issues are considered and assessed.Additionally, instructions for use (ifu) and patient education guides (peg) provide patients with guidance should skin irritation develop.

• Brand Name: UNIVERSAL ELECTRODE-PATCH
• Common Device Name: ELECTRODE - PATCH - UNIVERSAL 2 CHANNEL
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer (Section G): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer Contact: beverly okoh ; 1285 corporate center drive; suite 150; eagan, MN 55121
• MDR Report Key: 21752403
• Report Number: 2133409-2025-00014
• Device Sequence Number: 21244574
• Product Code: DSI
• UDI-Device Identifier: B146PE20
• UDI-Public: +B146PE20/$$1225P203002/Q1U
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K153473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2025

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: Lay User/Patient
• Device Model Number: 02-01609
• Device Catalogue Number: 02-01609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MCOT SENSOR - 3.0, 02-01846, SE23529835.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 14 YR
• Patient Sex: Female