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

Model Number 02-01609

Device Problem Biocompatibility (2886)

Patient Problems Local Reaction (2035); Skin Inflammation/ Irritation (4545)

Event Date 10/15/2023

Event Type  Injury  

Event Description

It was reported on 15 october 2023 the patient reported that after 1 day of wearing the universal patch their skin started itching.A couple days later the area started oozing.The patient removed part of the patch and applied antibiotic cream.Later, the patient was advised to removed the patch all together.On 18 october 2023 that patient reported that their physician confirmed she is allergic to adhesive and was prescribed prednisone and antibiotics as treatment.The patient was also advised to switch to vermed cloth electrodes.The patient services rep ordered coth electrodes.On 29 november 2023 the patient called again saying they were suppose to put the device back on by 27 october 2023 however, found out they were allergic to the cream that their doctor prescribed.The patient planned to continue with service on 18 december 2023 using the vermed cloth ectrodes and the lead wire adapter.To this date no subsequent skin irritation allegations have been reported.

• 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: 18827972
• MDR Text Key: 336855374
• Report Number: 2133409-2024-00012
• 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
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 02-01609
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2024
• 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: 69 YR
• Patient Sex: Female