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

Model Number	02-02045
Medical Device Problem Codes	Biocompatibility (2886); Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	08/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025 while the patient was sitting down in a chair noticed burn marks on their skin while wearing the electrode - patch - universal 2 channel.The patient stated that burn marks were on the skin where the wires extended.The patient didn't know if the device ever was hotter than normal however, the patient believed that the electrode - patch - universal 2 channel was the cause of the burn marks.The electrode - patch - universal 2 channel was never exposed to moisture.The patient reported that they kept the burn area clean and was going to see their doctor if the pain continues.Later the patient said the pain felt like an electrical shock along with their skin feeling like it was on fire.If the pain didn't improve, they would have gone to the emergency room (er).Additional information was received on (b)(6) 2025; the patient did seek medical attention and the area was covered after and unknown ointment was place.The patient didn't know if the ointment was a prescription, however, the patient was not given a prescription after seeing their doctor.Additional information was requested to clarify medical treatment however, they were unsuccessful.
Additional Manufacturer Narrative
It was reported that the patient experienced shock while wearing epatch sensor - 2.5.The sensor returned for investigation.The sensor was inspected for general physical integrity and found in good condition.Engineering evaluation could not confirm the allegation of shock.Device evaluation concludes that the sensor operated successfully, and no problem was identified.

• 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: 23027675
• Report Number: 2133409-2025-00089
• Device Sequence Number: 18437009
• Product Code: DSH
• UDI-Device Identifier: B146EP2510
• UDI-Public: +B146EP2510
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 12/23/2025

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: 02-02045
• Device Catalogue Number: 02-02045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2024
• 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 CHANNEL, 02-01609
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female