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 Code	Pain (1994)
Date of Event	04/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, the patient reported that the epatch sensor electrocuted the patient, flashed red, and became warm/overheated while being worn.The patient was driving at the time and felt a sensation traveling from the shoulder to the bicep.No medical attention was sought initially, and no medication was taken.The patient reported that symptoms improved after removing the device.No moisture exposure, visible skin marks, or unusual appearance of the patch were noted after removal.The patient later reported experiencing spasms and sought medical evaluation.The patient's spouse researched the device and mentioned an on/off button on the sensor.The patient stated that no similar symptoms had been experienced before the alleged malfunction.Follow-up report received on 30 april 2026 stated that the patient continued to experience spasms, with the most severe occurring three days earlier.The patient described twitching sensations extending from under the rib area to the abdomen and legs, along with frequent bathroom use.The patient reported that the patch had folded over and stuck to the device, and that the adhesive appeared melted, flexible, and floppy.After removal, an outline of the patch was visible on the skin and appeared lighter than the surrounding area.A burning sensation also developed in the affected area.The patient stated that the sensor caused pain, displayed a solid red light, and appeared to malfunction.An attorney contacted (b)(6) on 12 may 2026 regarding the returned device, which had been received on 27 april 2026.Confirmation of receipt was provided on 13 may 2026.Additional information from the attorney indicated that no issues were identified during the physician evaluation and that the patient's symptoms had improved after the device had been removed for several weeks.A legal notice dated 10 june 2026 was later received, alleging injuries related to the event and including supporting medical documentation.The notice stated that the patient had reached maximum recovery but continued to experience residual spasms and discomfort.A claim was made for loss of consortium, pain and suffering, inconvenience of daily life, and future pain and suffering.

• 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: 25858176
• Report Number: 2133409-2026-00133
• Device Sequence Number: 5470891
• Product Code: DSH
• UDI-Device Identifier: B146EP2510
• UDI-Public: +B146EP2510/$$+7961949D
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2026

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: 04/27/2026
• 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: 06/22/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 07/17/2026
• Supplement Report FDA Received Date: 09/14/2026
• 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: 53 YR
• Patient Sex: Female