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

Model Number	02-01609
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blister (4537)
Date of Event	07/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported skin irritation, blisters and discharge of fluids.Patient followed skin prep regimen.Patient stated they received prescription pills (benadryl chewable) and also used neosporin.Patient was using c6 patch and chose to switch to lead wire adaptor (lwa)/cloth electrodes.Patient decided to take break in service (bis) till replacement electrodes are received.
Additional Manufacturer Narrative
It was reported that the patient was experiencing blisters with discharge due to the universal patch and was prescribed medication.The universal patch was not returned for investigation however, pictures were provided.Engineering evaluation was unable to be performed as the electrode/device was not returned.Allegation is confirmed through images of patient skin irritation and 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: UNIVERSAL PATCH
• Common Device Name: MCOT C6 SENSOR
• 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: 17430443
• Report Number: 2133409-2023-00043
• Device Sequence Number: 2904747
• Product Code: DSI
• UDI-Device Identifier: B146PE20
• UDI-Public: B146PE20
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/19/2024

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
• Device Lot Number: U601797
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 02/19/2024
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female