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

Model Number	02-01846
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on 23 april 2025, when the patient was attempting to remove the mcot sensor - 3.0 out of the blue cradle in the universal patch and the mcot sensor - 3.0 began smoking.The patient admitted to prying the sensor out.The patient was not injured.A new sensor was order and the patient returned the sensor.
Additional Manufacturer Narrative
It was reported that the mcot sensor - 3.0 began smoking.The sensor was returned for investigation.The sensor was inspected for general physical integrity and found that the patient had pried open the sensor with something sharp.The sensor was punctured on the battery side.Evidence of the sensor smoking can be seen on the outside of the case damage, so additional testing could not be completed due to the safety issue.Engineering evaluation could confirm the allegation that the patient damaged the sensor when trying to remove the sensor from the patch.The battery was damaged when the attempt was made, and the device began to smoke.

• 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: 22074630
• Report Number: 2133409-2025-00019
• Device Sequence Number: 8530877
• Product Code: DSI
• UDI-Device Identifier: B146C6E10
• UDI-Public: +B146C6E10
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 09/03/2025
• 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
• Patient Age: 86 YR
• Patient Sex: Male