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

Model Number 01-02108

Device Problem Biocompatibility (2886)

Patient Problems Discomfort (2330); Superficial (First Degree) Burn (2685)

Event Type  Injury  

Event Description

It was reported that the patient was experiencing red, tender and burning feeling while wearing the electrode while using the flex adapter.The patient also reported the sensor never felt hot however the adhesive under the device and electrode turned to jelly and would ooze out.The patient used vanicream soap and water to clean and prep their skin and consulted with their physician.The patient spoke with their doctor and they were prescribed silver sulfadiazine 1% cream.After reporting the red, tender and burning feeling the patient disconnected the sensor.The patient services rep advised the patient of cloth electrodes.Cloth electrodes were ordered.

Manufacturer Narrative

It was reported that the patient experienced a skin irritation with redness, burning and a small amount of skin being removed.The device was not returned.Engineering evaluation was unable to be performed as the electrode was not returned.Allegation is able to be confirmed via the prescription from a doctor.As the device was noted to not be hot, the skin irritation 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.

• Brand Name: C6 MCOT PPM
• Type of Device: 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: 18818698
• MDR Text Key: 336685609
• Report Number: 2133409-2024-00010
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 01-02108
• Device Lot Number: 52522V13
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female