MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC EPATCH 2.5, BTH; EPATCH SENSOR - 2.5

Model Number	02-02045
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2025, the patient was experiencing a burning and itching sensation from electrode - patch - universal 2 channel and epatch sensor - 2.5.The patient reported that the burning and itching sensation woke them up.The patient called their doctor and made an appointment since the burn and itchiness were getting progressively worse.The patient was diagnosed a first-degree burn and was prescribed lidocaine and histamine.The patient does not know if the sensor overheated since they were sleeping at the time of the event.No additional information was provided.

• Brand Name: EPATCH 2.5, BTH
• Common Device Name: EPATCH SENSOR - 2.5
• 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: 23315797
• Report Number: 2133409-2025-00123
• Device Sequence Number: 5815058
• Product Code: DSH
• UDI-Device Identifier: B146EP2510
• UDI-Public: +B146EP2510/$$+7768493C
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 02-02045
• Device Catalogue Number: 02-02045
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/09/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ELECTRODE - PATCH - UNIVERSAL 2 CHANNELS, (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female