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

Model Number	02-02046
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	09/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, that the epatch sensor - 2.5 - ce overheated when placed on the patient's chest.The patient called the emergency medical services (ems).When ems arrived, they removed the sensor from the patient's chest.It was noted that the patient had a first-degree burn per doctor.No additional information was provided.
Additional Manufacturer Narrative
It was reported that the epatch sensor - 2.5 overheated which resulted in a first degree burn.Evaluation was unable to be performed as the device was not returned or is unable to be recovered.

• Brand Name: EPATCH 2.5, BTI
• Common Device Name: EPATCH SENSOR - 2.5 - CE
• 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: 23225196
• Report Number: 2133409-2025-00113
• Device Sequence Number: 9496007
• Product Code: DSH
• UDI-Device Identifier: B146EP2510
• UDI-Public: +B146EP2510
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 06/15/2026

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: 02-02046
• Device Catalogue Number: 02-02046
• 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: 09/09/2025
• Supplement Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 17 YR
• Patient Sex: Female