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

Model Number 02-01609

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blister (4537)

Event Date 07/19/2023

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 320125188
• Report Number: 2133409-2023-00043
• 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,Followup
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 02-01609
• Device Lot Number: U601797
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• 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: 71 YR
• Patient Sex: Female