MAUDE Adverse Event Report: Braemar Manufacturing, LLC ePatch 2.5, BTH; ePatch Sensor - 2.5

Model Number	02-02045
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Burn(s) (1757); Scar Tissue (2060); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Event or Problem Description
Alleged burn was initially reported on (b)(6) 2026.Patient was unable to specify whether they believed the issue was caused by the sensor or the patch, but stated the sensor was not hot.Patient was sitting and watching tv at the time of occurrence.Additional information was received on 14 august 2026 via gfe response.Patient was still unable to clarify whether they believed the burn to be from the sensor overheating or the patch.Patient described their symptoms as itchy chemical burns.Patient stated there was scarring, a red spot, and hurting.Patient stated they only experienced symptoms with one specific patch/sensor.Patient stated the monitor was warm, but enrollment shows they were sent an epatch kit which included an epatch sensor but not a monitor.No medical attention was sought.Additional information was received on 02 september 2026 via gfe response.Patient stated that no medical attention was sought for the skin injury or scar.Patient stated that the scar had not improved since initially reporting it on (b)(6) 2026.No further information to provide.

• 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: 50734184
• Report Number: 2133409-2026-00193
• Device Sequence Number: 10574796
• Product Code: DSH
• UDI-Device Identifier: B146EP2510
• UDI-Public: +B146EP2510
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 09/11/2026

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: 08/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 68 YR
• Patient Sex: Female