MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 MCOT UNIVERSAL PATCH; C^MCOT UNIVERSAL PATCH

Model Number	02-01609
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Biocompatibility (2886)
Health Effect - Clinical Codes	Skin Tears (2516); Blister (4537); Skin Inflammation/ Irritation (4545)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient reported open, wet, and bleeding blisters.Skin was prepped by washing with warm water, soap and dried.Patient went to er, cortisone cream applied.Patient wore monitor for 5 days and had to remove due to the skin irritation.Patient returned the monitor, but did not return the patch which is what caused the skin issue.Patient discontinued service.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.
Event or Problem Description
Patient reported open, wet, and bleeding blisters.Skin was prepped by washing with warm water, soap and dried.Patient went to er, cortisone cream applied.Patient wore monitor for 5 days and had to remove due to the skin irritation.Patient returned the monitor, but did not return the patch which is what caused the skin issue.Patient discontinued service.

• Brand Name: C6 MCOT UNIVERSAL PATCH
• Common Device Name: C^MCOT UNIVERSAL 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: 16401162
• Report Number: 2133409-2023-00004
• Device Sequence Number: 5706092
• Product Code: DSI
• UDI-Device Identifier: B146PE20
• UDI-Public: B146PE20
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/17/2023

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: 02-01609
• Device Lot Number: P201496
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female