MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6S 2.5,BTH; C6 MCOT

Model Number C6S 2.5,BTH

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Skin Infection (4544); Skin Inflammation/ Irritation (4545); Drug Resistant Bacterial Infection (4553)

Event Date 08/09/2022

Event Type  Injury  

Manufacturer Narrative

The patient did consult a medical professional and was prescribed antibiotics.It was stated that patient was wearing the device less than a week before mrsa infection appeared.

Event Description

This patient stated he was diagnosed with mrsa as per his md and was told either he got it from the mcot patch or lwa.

Manufacturer Narrative

Devices associated with this event have been received on 31aug2022.Due to the allegation of contamination that the package may have been in contact with mrsa, the package cannot be opened and will be disposed of according to local biohazard laws.There is no allegation or evidence of a device malfunction.It was identified that the patient was using the lead wire adapter (lwa) which utilized a 3rd party manufactured electrode.This is the accessory that makes continuous contact with the patient and is likely the cause of the skin irritation.Braemar devices are not known to cause methicillin resistant staphylococcus aureus(mrsa).It has been confirmed that the patient did not follow instructed skin care preparation/regiment before placing the electrode on their skin.Biotel heart distribution follows procedure for cleaning before being shipped to patients.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: C6S 2.5,BTH
• Type of Device: C6 MCOT
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer (Section G): BRAEMAR MANUFACTURING, LLC; 1285 corporate center dr; suite 150; eagan MN 56121
• Manufacturer Contact: beverly okoh ; 1285 corporate center drive; suite 150; eagan, MN 55121 ; 6124263781
• MDR Report Key: 15307186
• MDR Text Key: 298759919
• Report Number: 2133409-2022-00004
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: C6S 2.5,BTH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Male