MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 WITH MCOT PATCH

Lot Number P20117-1

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Erythema (1840); Superficial (First Degree) Burn (2685); Skin Inflammation/ Irritation (4545)

Event Date 10/27/2022

Event Type  Injury  

Manufacturer Narrative

Patient consulted a clinician and was diagnosed with a first degree burn.Patient was prescribed silvadene cream for medical treatment.Patient discontinued use of device due to skin irritation.

Event Description

Biotel heart customer support notified braemar that the patient called with skin irritation and stated she had to go to emergency room and was diagnosed with a first degree burn on chest and was prescribed silvadene cream.

Manufacturer Narrative

Engineering evaluation is not able to be performed as the sensor is with a new patient.The sensor has been functioning as intended and without further allegation.Due to the continued function of the sensor, it did not likely experience an overheat event.Electrode (p20117-1) - the images show skin irritations at the site of electrode placement.It is most probable cause of the skin issue is that the patient experienced a bio-incompatibility event to the electrode that was perceived as a thermal event.Electrodes are single use devices.In this case the electrode was not returned for evaluation.Device due to skin irritation.The electrodes were not available for return by patient as these are single use devices.Patient discontinued usage of the device.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 WITH MCOT PATCH
• Type of Device: C6 WITH MCOT PATCH
• 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: 15736583
• MDR Text Key: 303094724
• Report Number: 2133409-2022-00013
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171410
• 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: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: P20117-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Sex: Female