MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 SENSOR 3.0; BRAEMAR TELEMETRY PATCH SYSTEM

Model Number	02-01846
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Codes	Electric Shock (2554); Superficial (First Degree) Burn (2685)
Date of Event	03/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2025, patient stated they were having a burning sensation and shocking while wearing the mcot sensor - 3.0.Patient reported the related components that were involved was the sensor and the universal patch.Patient was performing normal activity during the event and attempted placing on a new patch but with no resolution.Patient has removed the device on (b)(6) 2025 but have been having the issue occur for a week.Additional information received on (b)(6) 2025, patient reported the symptoms improved after removing the device but has remnants of burn marks on the skin and the muscle was tender.Patient has not experienced the symptoms prior to wearing the device.Patient reported taking a shower according to the directions and covered the device to prevent water damage.Patient also stated they were not showering at the time of the event but notice moisture under the patch when removing the device after 5 days and had the sensation all week.Patient did not report having any implantable medical devices.There was no reported additional electronics in use at the time of the event.Patient was unable to provide the frequency of shock occurrence while wearing the sensor.There was no reported significant difference in the visual appearance or changes to the universal patch when removing it.Additional information received on (b)(6) 2025 that patient reported arriving to the emergency room (er) and was treated for the skin irritation with oral steroids and ointment.
Additional Manufacturer Narrative
It was reported that the mcot sensor - 3.0 caused a burning shocking sensation.The mcot sensor - 3.0 was not returned for device evaluation.Evaluation was unable to be performed as the device was not returned or is unable to be recovered.Engineering evaluation was unable to be performed as the device was not returned to chu engineering.No images have been provided by the patient to corroborate the allegation.

• Brand Name: C6 SENSOR 3.0
• Common Device Name: BRAEMAR TELEMETRY PATCH SYSTEM
• 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: 21733365
• Report Number: 2133409-2025-00010
• Device Sequence Number: 14508833
• Product Code: DSI
• UDI-Device Identifier: B146C6E10
• UDI-Public: +B146C6E10
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K153473
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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: 02-01846
• 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: Not provided
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2022
• 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: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male