MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 MCOT UNIVERSAL PATCH; C^MCOT UNIVERSAL PATCH

Lot Number U600778

Device Problems Patient-Device Incompatibility (2682); Biocompatibility (2886)

Patient Problems Itching Sensation (1943); Skin Inflammation/ Irritation (4545)

Event Date 08/12/2022

Event Type  Injury  

Manufacturer Narrative

Patient reported burned with redness and scaring and itching and irritation.Red with some swelling and raised bumps.Skin was prepped using warm water and soap then dried the area.Patient saw their primary care physician and used prescribed topical cream.Has no history of skin sensitives.The patient continued service.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.

Event Description

Patient reported burned with redness and scaring and itching and irritation.Red with some swelling and raised bumps.Skin was prepped using warm water and soap then dried the area.Patient saw their primary care physician and used prescribed topical cream.Has no history of skin sensitives.The patient continued service.

• Brand Name: C6 MCOT UNIVERSAL PATCH
• Type of Device: C^MCOT UNIVERSAL PATCH
• 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: 16373438
• MDR Text Key: 309508494
• Report Number: 2133409-2023-00003
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: U600778
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/03/2023
• Initial Date FDA Received: 02/14/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female