MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 SENSOR; MCOT SENSOR - 2.5

Model Number	02-01606
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the mcot sensor - 2.5 got stuck in the charger.The sensor was returned for investigation.The allegation states that the sensor was stuck in the charger.The sensor and charger were able to be separated and found that the sensor melted inside the charger.There is evidence on the back of the sensor and also melted material was found inside the charger.There is a strong burnt smell on both the devices.Additional testing could not be completed due to the melted damage.Engineering evaluation confirmed that the sensor melted inside the charger.The sensor likely heated up inside the charger for an unknown reason.Heat stress testing could not be completed due to the damage to the device.
Event or Problem Description
It was reported that the mcot sensor - 2.5 got stuck in the charger.Troubleshooting was performed however, the patient was still unable to remove the sensor from the charger.The patient confirmed that they did remove the sensor from the universal patch before placing the sensor into the charger and that the sensor was not exposed to moisture prior to the event.A replacement was ordered.No additional information was provided.

• Brand Name: C6 SENSOR
• Common Device Name: MCOT 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: 24415005
• Report Number: 2133409-2026-00025
• Device Sequence Number: 10577521
• Product Code: DSI
• UDI-Device Identifier: B146C6D10
• UDI-Public: +B146C6D10
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 02/23/2026

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: 02-01606
• Device Catalogue Number: 02-01606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2022
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Sex: Female