MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 MCOT PPM

Model Number 02-01846

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Dry Mouth (4485); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

It was reported on 16 february 2024 after the sensor was placed the patient started to experience their throat swelling, headaches and dry mouth.About 30 minutes after taking the sensor off their throat was not swelling anymore on the outside.They were still experiencing swellin inside the troat.The patient went to the doctor and had tests and scans perfromed however, nothing could be found.It is unknown what is thought to have caused the throat swelling.The patient discontinued service.

• Brand Name: C6 MCOT PPM
• Type of Device: C6 MCOT PPM
• 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: 18857715
• MDR Text Key: 337126415
• Report Number: 2133409-2024-00018
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: B146C6E10
• UDI-Public: B146C6E10
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 02-01846
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male