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

Model Number	02-02045
Medical Device Problem Codes	Overheating of Device (1437); Unintended Electrical Shock (4018)
Health Effect - Clinical Codes	Electric Shock (2554); Superficial (First Degree) Burn (2685)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on an unknown date the epatch sensor - 2.5 shocked and burnt the patient and an increase in temperature was noted.The patient reported that they went to a walk-in clinic where they applied cream to the affected area.The patient stated that the device was placed originally at the prescribing clinic and the skin prep is unknown.
Additional Manufacturer Narrative
It was reported that the epatch sensor - 2.5 shocked and burned the patient.The device was returned for investigation.The sensor was inspected for general physical integrity and the exterior housing was found in good condition, only minor wear was observed.Engineering evaluation could not confirm the reported event of "patient called stated the device shocked and then burnt her".There was no evidence of any leakage of current or temperature excursions as the sensor passed functional testing.Device evaluation concluded that the allegation is unconfirmed as functional testing verified there was no product malfunction or defect.

• 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: 20980921
• Report Number: 2133409-2024-00066
• Device Sequence Number: 20944282
• Product Code: DSI
• UDI-Device Identifier: B146EP2510
• UDI-Public: +B146EP2510
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K081444
• 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): 08/12/2025

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?: Yes
• Device Model 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: 12/10/2024
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 51 YR
• Patient Sex: Female