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

Model Number 02-01846

Device Problems Melted (1385); Overheating of Device (1437)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 01/05/2024

Event Type  Injury  

Event Description

It was reported that patient was sitting in their kitchen when the sensor became really hot while wearing the universal patch.The patient removed the sensor and patch and noted a burn at the top/middle of the chest where the sensor/patch was placed.The patient reported that this began about 30 minutes after starting service.The patient reported that there was no sparks but the device was hot and started to melt.The patient reported that the device was working as expected when first pulled it out of the box.The patient used aquaphor on the burn.The patient reported no prior skin sensibility/allergies.A replacement device was ordered.

Manufacturer Narrative

It was reported that the patient received a burn from the sensor and the sensor melted.The device was returned for investigation.Device was inspected for general physical integrity and found physical damage looking like pry marks on that battery side of the sensor.Device was not able to charge and device was badly damaged due to customer misuse of the device.The allegation of heat and melting the device is confirmed due to the customer damaging the device.

• 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: 18587791
• MDR Text Key: 333848609
• Report Number: 2133409-2024-00007
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: B146C6E10
• UDI-Public: B146C6E10
• 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: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• 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
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Sex: Female