MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC UNIVERSAL ELECTRODE-PATCH; C6 MCOT PPM

Model Number	02-01609
Medical Device Problem Codes	Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Peeling (1999); Skin Tears (2516)
Date of Event	04/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on 26 april 2024 when the patient was removing the universal patch to swap out and their skin came off.The patient sought medical attention and was given cortisone cream.The patient did not report any pre exisiting skin sensitibity and prepped their skin at the doctor's office by cleaning and drying.
Additional Manufacturer Narrative
It was reported that the patient experienced damaged skin due to the mcot universal patch.The universal patch was not returned for device evaluation.Engineering evaluation was unable to be performed on the patch as it is single use and was not returned.Allegation is confirmed through images of patient skin irritation or a prescription from a medical professional and is most probable to be a bio-incompatibility issue with the electrode adhesive and/or hydrogel components.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: UNIVERSAL ELECTRODE-PATCH
• Common Device Name: 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: 19414978
• Report Number: 2133409-2024-00030
• Device Sequence Number: 3263674
• Product Code: DSI
• UDI-Device Identifier: B146PE20
• UDI-Public: +B146PE20/$$0325P202312/Q1X
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female