MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6S MCOT UNIT

Lot Number UNKNOWN

Device Problems Gel Leak (1267); Patient Device Interaction Problem (4001)

Patient Problems Bruise/Contusion (1754); Erythema (1840); Unspecified Respiratory Problem (4464); Blister (4537)

Event Date 11/22/2021

Event Type  Injury  

Event Description

Biotel heart distributor notified braemar that a patient alleged that the they experienced a severe reaction to the gel from the patch.She stated that after wearing the patch for a little bit she started feeling symptoms of anaphylactic shock.She also experienced shortness of breath, bruising, skin erythema (breaking out)), and bleeding from the patch site.

Manufacturer Narrative

This patient called in to complain of a severe reaction to the gel from the patch per her complaint.After wearing the patch for a little bit she started feeling symptoms of anaphylactic shock.She also was experiencing shortness of breath, bruising, broken out, and bleeding from the patch site.She went to the hospital, and they gave her steroids to help.She is currently feeling better but will be removing the device and sending back.She will consult with her doctor first before deciding to continue use of device.Third party manufacturer of electrode was notified of the incident.

Manufacturer Narrative

Sensor (b)(6)- engineering evaluation was unable to be performed as the device is already with another patient.The device has been functioning as intended and without complaint and due to this it is unlikely that the sensor contributed to the allegation.Electrode (p200672) universal - engineering evaluation was unable to be performed as the device was not returned.Electrode is a single use device and makes continuous contact with a patient's skin.The most probable cause of the skin issue is that the patient experienced a bio-incompatibility event to the electrode adhesive.Marsi, skin burn, and associated symptoms may inherently occur under the course of ecg monitoring.No single factor or combination of factors can be attributable to electrode skin irritation and associated symptoms.The product labeling advises patients of alternate options and other steps to take if skin irritation develops, including healthcare professional contact as needed initially a third party manufacturer was identified as the electrode worn by the patient at the time of the incident.It was discovered that the electrode was actually the universal patch, manufactured by braemar, inc.Third party manufacturer of electrode was notified of the change and that their electrode, although shipped to the patient, was not being worn by the patient at the time of the incident.The electrodes were not available for return by patient as these are single use devices.Patient discontinued usage of the device.

• Brand Name: C6S MCOT UNIT
• Type of Device: C6S MCOT UNIT
• 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: 15397913
• MDR Text Key: 299663894
• Report Number: 2133409-2022-00007
• Device Sequence Number: 1
• Product Code: DSI
• 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: Consumer,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2022
• 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 Age: 22 YR
• Patient Sex: Female