MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 SENSOR 3.0; MCOT SENSOR - 3.0

Model Number	02-01846
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Skin Inflammation/ Irritation (4545)
Date of Event	04/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported on (b)(6) 2026, the patient experienced skin irritation resulting in burn scars while wearing the electrode - patch - universal 2 channels.The patient then reported concerns related to the mcot sensor 3.0 gold plates, as the patient was unsure whether the reaction was caused by the sensor or the patch adhesive.Philips am&d is currently conducting an investigation into the reported issue.
Event or Problem Description
It was reported on (b)(6) 2026, the patient experienced skin irritation resulting in burn scars while wearing the electrode - patch - universal 2 channels.The patient later reported concerns related to the mcot sensor 3.0 gold plates, as the patient was unsure whether the reaction was caused by the sensor or the patch adhesive.The patient stated that the burn was not related to sensor overheating or exposure to unexpected temperatures.The patient reported that both the sensor and patch were exposed to a 115°f heated hot yoga environment.The patient was informed that the sensor should not be worn in environments with extreme heat, including heated yoga rooms.However, a the patient reported that a hospital employee advised that wearing the sensor in the heated yoga room was acceptable.The patient sought medical attention and was awaiting follow-up from their physician at the time of reporting.The patient self-treated the affected area using neosporin.It was noted that the patient did not perform proper skin preparation and used an alcohol wipe prior to application.The patient reported no prior history of skin sensitivity or allergies.The patient was educated on proper device use per the patient education guide (peg) and was offered a lead wire adapter (lwa) and flex kit with electrodes.The patient declined these options and elected for an early disconnection.Multiple follow-up attempts were made to contact the patient; however, these attempts were unsuccessful.No additional information was provided.

• Brand Name: C6 SENSOR 3.0
• Common Device Name: MCOT SENSOR - 3.0
• 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: 25116879
• Report Number: 2133409-2026-00085
• Device Sequence Number: 10249115
• Product Code: DSI
• UDI-Device Identifier: B146C6E10
• UDI-Public: +B146C6E10/$$+7SE24036414R
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2026

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: 02-01846
• Device Catalogue Number: 02-01846
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/01/2026
• 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: 04/18/2026
• Supplement Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 08/26/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ELECTRODE - PATCH - UNIVERSAL 2 CHANNEL, 02-01609
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female