MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 MCOT PPM

Model Number	01-01609
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was experiencing skin irritation under the patch.Other electrode options were offered to the patient however, the patient wanted to keep using the universal patch.The patient was prescribed a steroid ointment for the skin irritation and continued with service.
Additional Manufacturer Narrative
It was reported that the patient experienced an allergic reaction while wearing the universal patch.The universal pacth was not returned.Engineering evaluation was unable to be performed as the electrode was not returned.Allegation is confirmed through the need for a prescription 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.
Additional Manufacturer Narrative
**udi related data quality updates only**.

• Brand Name: C6 MCOT PPM
• Common Device Name: C6 MCOT PPM
• 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: 18083415
• Report Number: 2133409-2023-00070
• Device Sequence Number: 6629586
• Product Code: DSI
• UDI-Device Identifier: B146PE21
• UDI-Public: +B146PE21/$$0924U601686/Q40L
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 07/15/2024

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: 01-01609
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 01/23/2024; 07/08/2024
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 02/05/2024; 07/15/2024
• 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): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female