MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 MCOT

Model Number UNIT,C6M,A10E,U / UNIT,C6S 3.0,BTH

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Skin Discoloration (2074)

Event Date 04/01/2022

Event Type  Injury  

Manufacturer Narrative

The patient did seek medical attention for the skin condition.The physician did not prescribe medication to treat the skin condition.The patient was able to wear the device for 4 days and the physician determined that enough data was collected and that device use could be discontinued.Based on the evidence and medical affairs consult that had been reviewed, the patient physiological factors indicated that there is a high-risk probability of darker skin to have change in pigmentation.The patient also has thicker scarring than usual as noted in the adjacent supra sternal incision.This could possibly have a increased risk of developing scarring.In conclusion due to the evidence of hyperpigmentation scarring and not knowing if this the condition will fade over time, we have decided to conservatively report this issue.

Event Description

Mother of patient reported that her son experienced scarring based on the skin irritation from the mcot device.The mother reached out to her physician to determine best course of action and was instructed to rotate the placement of the patch on the patient.Later, the physician concluded that they had enough data and it was best to finish the monitoring period after 4 days.

Manufacturer Narrative

The event was caused by the electrodes which are not manufactured by braemar.Based on the evidence and medical affairs consult that had been reviewed, the patient physiological factors indicated that there is a high-risk probability of darker skin to have change in pigmentation.The patient also has thicker scarring than usual as noted in the adjacent supra sternal incision.This could possibly have a increased risk of developing scarring.In conclusion due to the evidence of hyperpigmentation scarring and not knowing if this the condition will fade over time, we have decided to conservatively report this issue.

• Brand Name: C6 MCOT
• Type of Device: C6 MCOT
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer (Section G): BRAEMAR MANUFACTURING, LLC; 1285 corporate center dr; suite 150; eagan MN 56121
• Manufacturer Contact: beverly okoh ; 1285 corporate center drive; suite 150; eagan, MN 55121 ; 6124263781
• MDR Report Key: 14253096
• MDR Text Key: 290420901
• Report Number: 2133409-2022-00002
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNIT,C6M,A10E,U / UNIT,C6S 3.0,BTH
• Device Lot Number: SENSOR SE23439626
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 7 YR
• Patient Sex: Male