MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6S 2.5,BTH; C6 MCOT

Model Number	C6S 2.5,BTH
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Biocompatibility (2886); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545)
Date of Event	04/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Braemar manufacturing, llc received an allegation of burns to a patient's chest area.Braemar attempted to request a device return from the customer, but the customer notified that the device was deemed "lost/stolen" and could not be retrieved or returned.The complainant was not able to provide additional information on the allegation of burns associated with the complaint.The qualitative description of "burns" could not be substantiated with further description and/or pictures to assess the claim.As a result, a skin irritation categorization could not be performed.While the complainant indicated a claim of medical consult, there is no evidence or allegation that medical or prescriptive treatment was necessitated.Sensor does not make continuous contact with patients skin.A review of the electrodes sent with the mcot package shows that the vermed electrodes were sent to the patient and have an adhesive which makes contact with the skin and is likely to be the cause of the alleged event.
Event or Problem Description
When patient removed device for the first time as instructed, it is alleged that she sustained injuries (bleeding and burn marks).

• Brand Name: C6S 2.5,BTH
• Common Device Name: C6 MCOT
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer (Section G): BRAEMAR MANUFACTURING, LLC; 1285 corporate center dr; suite 150; eagan MN 56121
• Manufacturer Contact: beverly okoh ; 1285 corporate center drive; suite 150; eagan, MN 55121 ; 6124263781
• MDR Report Key: 15089466
• Report Number: 2133409-2022-00003
• Device Sequence Number: 14696105
• Product Code: DSI
• UDI-Device Identifier: B146BTPM0
• UDI-Public: B146BTPM0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: C6S 2.5,BTH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female