MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC MCOT PATCH

Model Number MCOT PATCH

Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Burn(s) (1757); Skin Irritation (2076)

Event Date 12/06/2019

Event Type  Injury  

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 Description

The patient presented to their healthcare provider with a skin burn from device usage.Patient reported seeking medical attention for staph infection.

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 Description

The patient presented to their healthcare provider with skin irritation symptoms from device usage.Patient reported seeking medical attention/treatment.

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 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
• Type of Device: MCOT PATCH
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan, mn MN 55121
• MDR Report Key: 9548408
• MDR Text Key: 174673311
• Report Number: 2133409-2020-00001
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: B146MCP0
• UDI-Public: B146MCP0
• Combination Product (y/n): N
• PMA/PMN Number: K153473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 09/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MCOT PATCH
• Device Catalogue Number: 390-0131-02
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR