MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC MCOT C6; UNIVERSAL PATCH V2.0 BLUE

Model Number	02-01609
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Reaction to Medicinal Component of Device (4574)
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported redness over the past couple weeks with a "burning fire" feeling after changing the patch.The patient drove to the hospital and went to the emergency room (er).The er doctor said the burn on the patient's skin was not a burn but a "dermatology reaction" due to the patch.The patch was peeling the patient's skin off layer by layer.The er doctor prescribed a steroid ointment and antibiotics and was advised to remove the device and return it.The patient does not have a history of pre-existing skin sensitivities.
Additional Manufacturer Narrative
It was reported that the patient experienced a burning "like fire" reaction after removing the universal patch.Medical attention was sought.The device/universal patch was not returned for investigation.Pictures were not provided; however, the patient did require a written prescription.The cause is likely due to biocompatibility issue with the universal patch 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: MCOT C6
• Common Device Name: UNIVERSAL PATCH V2.0 BLUE
• 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: 17573038
• Report Number: 2133409-2023-00046
• Device Sequence Number: 8886944
• Product Code: DSI
• UDI-Device Identifier: B146PE20
• UDI-Public: B146PE20
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/29/2024

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: Not provided
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 01/29/2024
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 21 YR
• Patient Sex: Female