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

Model Number	02-01609
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Rash (2033); Skin Inflammation/ Irritation (4545)
Date of Event	02/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on 03 february 2025 that on (b)(6) 2025 when the patient's mother was removing the epatch sensor - 2.5 and electrode - patch - universal 2 channel it was noted that the patient was experiencing raw and bumpy skin irritations.Additional information was received on 06 february 2025 that reported that the patient sought medical attention and was prescribed triamcinolone acetonide.25%.It was noted that the device was originally placed at the patient's doctor's office and that the patient had experienced skin sensitivities from bandage and brace.The patient's symptoms did improve after remove the device.The patient was also sent alternative electrodes to complete service.
Additional Manufacturer Narrative
It was reported that the electrode - patch - universal 2 channel caused a severe skin irritation that required medical attention.The electrode - patch - universal 2 channel was not returned for device evaluation.He 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, pediatric patient.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: EPATCH
• 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: 21446883
• Report Number: 2133409-2025-00006
• Device Sequence Number: 15243432
• Product Code: DSH
• UDI-Device Identifier: B146PE20
• UDI-Public: +B146PE20/$$0426U603435/Q18
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171410
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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
• 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: 02/03/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 9 YR
• Patient Sex: Male