MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC UNIVERSAL ELECTRODE-PATCH; ELECTRODE - PATCH - UNIVERSAL 2 CHANNEL

Model Number	02-01609
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2024 that patient started experiencing itching and scaring on the their skin.The patient went to urgent care and while at urgent care they removed the c6 mcot sensor and universal patch.Upon removing the device it was noted that a piece of metal poking the patient and it thought it was from the universal patch.The patient was prescribed mupirocin ointment.The patient did perform skin prep prior to placing the device, however it was unknown if the patient followed the proper skin prep.The patient does have a history of skin sensitivity to adhesives and does not have any sensitivity/allergies to metal.
Additional Manufacturer Narrative
It was reported that the patient was experiencing discomfort from the metal on the universal patch.The universal patch was not returned for evaluation.Engineering evaluation was unable to be performed as the universal electrode patch was not returned to chu engineering.The universal patch is single use and disposed after use; therefore, it is not likely to be returned.No objective evidence has been provided by the patient to corroborate the allegation; however, the patient stated they have a skin sensitivity to adhesives.Any skin irritation is most probable to be a bio-incompatibility issue with 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.

• Brand Name: UNIVERSAL ELECTRODE-PATCH
• Common Device Name: ELECTRODE - PATCH - UNIVERSAL 2 CHANNEL
• 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: 20326381
• Report Number: 2133409-2024-00060
• Device Sequence Number: 18049857
• Product Code: DSI
• UDI-Device Identifier: B146PE20
• UDI-Public: +B146PE20/$$1125E439980/Q11
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K081444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2024

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 Model Number: 02-01609
• Device Lot Number: E439980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male