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

Model Number C6S 2.5,BTH

Device Problems Patient-Device Incompatibility (2682); Biocompatibility (2886); Patient Device Interaction Problem (4001)

Patient Problems Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545)

Event Date 04/08/2021

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 296465112
• Report Number: 2133409-2022-00003
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: B146BTPM0
• UDI-Public: B146BTPM0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: C6S 2.5,BTH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female