MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC MCOT PATCH

Model Number	MCOT PATCH
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Burn(s) (1757); Skin Irritation (2076)
Date of Event	12/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has made attempts to obtain additional information regarding the alleged event (e.G., pictures) and device return from the distributor.Additional follow-up attempt(s) will be made to obtain more information from the patient.
Event or Problem Description
The patient presented to their healthcare provider with a skin burn from device usage.Patient reported seeking medical attention for staph infection.
Additional Manufacturer Narrative
The manufacturer has made attempts to obtain additional information regarding the alleged event (e.G., pictures) and device return from the distributor.Additional follow-up attempt(s) were made to obtain more information regarding the patient.The customer/distributor made outreach attempts to the patients (no additional contact could be established).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 this risk and the steps to take if skin irritation develops, including healthcare professional contact as needed.No additional information is known to braemar manufacturing, llc.
Event or Problem Description
The patient presented to their healthcare provider with skin irritation symptoms from device usage.Patient reported seeking medical attention/treatment.
Additional Manufacturer Narrative
The manufacturer has made attempts to obtain additional information regarding the alleged event (e.G., pictures) and device return from the distributor.Additional follow-up attempt(s) were made to obtain more information regarding the patient.The customer/distributor made outreach attempts to the patients (no additional contact could be established).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 this risk and the steps to take if skin irritation develops, including healthcare professional contact as needed.
Event or Problem Description
The patient presented to their healthcare provider with skin irritation symptoms from device usage.Patient reported seeking medical attention/treatment.

• Brand Name: MCOT PATCH
• Common Device Name: MCOT PATCH
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan, mn MN 55121
• MDR Report Key: 9548408
• Report Number: 2133409-2020-00001
• Device Sequence Number: 13562628
• Product Code: DSI
• UDI-Device Identifier: B146MCP0
• UDI-Public: B146MCP0
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K153473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2020

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: MCOT PATCH
• Device Catalogue Number: 390-0131-02
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 12/06/2019; 12/06/2019
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 08/07/2020; 09/13/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 41 YR