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

Model Number A10091

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

Patient Problem Caustic/Chemical Burns (2549)

Event Date 08/25/2023

Event Type  Injury  

Event Description

The patient reported they were experiencing severe skin burns while using he c6 sensor with flex adaptor.The patient stated they had lumps and burns from the metal attachment.The patient followed the recommended skin prep.Patient reported that they are no longer wanting to continue with service.The patient used sulfadiazine cream on the severe skin burns.

• 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: 17802634
• MDR Text Key: 324112400
• Report Number: 2133409-2023-00057
• 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: 09/22/2023

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: A10091
• Device Lot Number: 255322V13
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/25/2023
• Initial Date FDA Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: C6 SENSOR, SE23507635
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female