MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 MCOT PPM; UNIT,C6S 3.0,BTH

Model Number 02-01846

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 09/15/2023

Event Type  Injury  

Event Description

Beginning 15 september 2023, the patient called and emailed to report that they will be returning the device because the second batch of vermed electrodes caused blisters and bleeding from gel that leaked out of the electrodes.The patient saw their doctor, who prescribed clobetasol propionate cream usp,0.05%.After applying it twice daily for 14 days, the patient's skin healed but now has scarring.The patient reported that they cleaned and dried their skin properly before applying the electrodes and has no prior skin sensitivity/allergy.

Manufacturer Narrative

It was reported that the patient wearing vermed electrodes that caused blistered and bleeding.The electrodes and device were not returned for investigation.Engineering evaluation was unable to be performed as the electrode/device was not returned.Allegation is able to be confirmed as there are images of patient skin, and any 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: UNIT,C6S 3.0,BTH
• 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: 18384673
• MDR Text Key: 331231081
• Report Number: 2133409-2023-00077
• 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: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 02-01846
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2024
• 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
• Treatment: VERMED ELECTRODES, 01-02108, 42622V13
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female