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 Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on 16 august 2024 after receiving their mcot kit, it was noted that it was soiled and because of it being soiled it gave the patient a skin infection.The patient reported that they have an irritation underneath the patch.The patient continued by stating the patches weren't soiled, but the sensor was and because the sensor was handled it now created an infection on the skin.The patient said they have 6 dots that are oozing with blood and pus.The patient said they used soap and water only to prep the skin.The patient said they contacted their doctor about sending a soiled device and the patient claims their doctor said it was urgent for them to get their heart monitored.The patient continued by stating that no one told them to put on the soiled device on but since they have heart issues, they felt that they should wear it anyway.The patient attempted to clean they device themselves by using isopropyl alcohol and a toothbrush to clean all the nooks and crannies.The patient did not seek any medical attention for the irritation at this time and reported no history of skin sensitivities.The patient also reported that the irritation occurred 24 hours prior and since has removed the device.Additional information was received on 22 august 2024 stating they didn't seek medication attention was but was given medication by their farther who is a physician.The patient took amoxicillin.
Additional Manufacturer Narrative
It was reported that the device was dirty upon receiving.The device was returned for device evaluation.The sensor was inspected for general physical integrity and found in good condition.On the front cover, there is a stain on the top of the sensor.Engineering evaluation could not confirm the allegation that the device was dirty when it was taken out of the package.All devices are disinfected prior to being sent to patients according to (b)(6).There is no evidence to conclude that the sensor could have caused or contributed to the skin irritation associated with the other complaints listed above.Marsi, skin burn, and associated symptoms may inherently occur under the course of ecg monitoring.No single factor or combination of factors can be attributable to electrode skin irritation and associated symptoms.The product labeling advises patients of alternate options and other steps to take if skin irritation develops, including healthcare professional contact as needed.

• 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: 20214602
• Report Number: 2133409-2024-00057
• Device Sequence Number: 7202654
• Product Code: DSI
• UDI-Device Identifier: B146C6E10
• UDI-Public: +B146C6E10
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K081444
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male