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

Model Number 02-01846

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

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Event Description

It was reported by the patient's mother that her daughter complained the device was burning her.Upon removing the device, the mother noticed burn marks on the device connectors and also small red blisters on the child's skin.She was unsure if there was an allergic reaction or if the skin appearance was from the device itself because of the burn marks on the connectors.The mother reported that the patient received medical treatment and was prescribed an ointment.Patient mother advised patient took a shower earlier in the day that was the prior water exposer before the event occurred.This is related to mfr 2133409-2023-00072.

Manufacturer Narrative

It was reported device got hot and leaved burns on the patient.The device was returned for investigation.Device was able to charge, and device investigation found that the temperature for the device was within normal limits.Engineering evaluation was unable to be performed as the electrode was not returned.Allegation is confirmed as the image of patient skin irritation shows and any skin irritation is most probable to be a bio-incompatibility issue with the electrode adhesive.

• 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: 18148189
• MDR Text Key: 328269882
• Report Number: 2133409-2023-00072
• 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: 01/04/2024

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 02-01846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 02-01609, P202115.
• Patient Outcome(s): Required Intervention
• Patient Age: 10 YR
• Patient Sex: Female