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

Model Number 02-01609

Device Problem Biocompatibility (2886)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 10/02/2023

Event Type  Injury  

Event Description

It was reported that the patient was experiencing red, itchy skin due to the adhesive.The patient reported that they were prescribed steroid cream to treat the skin irritation.The patient prepped her skin with soap and water.There were prior history of skin sensitivities/allergies.The patient was offered to switch to the lwa (lead wire adaptor) or flex adapter with cloth electrodes.A replacement device was also offered however, the patient wanted to follow up with their doctor.The patient's doctor advised that patient should continue service and was set up with flex device and cloth electrodes.

Manufacturer Narrative

It was reported that the patient experienced red, itchy skin during service.The electrode did not return however, the sensor did.Device was able to charge, and device investigation found that the temperature for the device was within normal limits.Device was opened and confirmed that there was no internal damage or corrosion on the inside of the device.Engineering evaluation on skin irritation is most probable to be a bio-incompatibility issue with the electrode adhesive.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 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: 18149086
• MDR Text Key: 328288413
• Report Number: 2133409-2023-00073
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: B146PE20
• UDI-Public: B146PE20
• 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: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 02-01609
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 67 YR
• Patient Sex: Female