MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC UNIVERSAL ELECTRODE-PATCH; C6 MCOT PPM

Model Number	02-01609
Medical Device Problem Codes	Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	05/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on 02 may 2024 a 1 year and 2 month year old patient experienced a skin brun under where th c6 sensor and universal 2 channel electrodes was sitting.The patient's mother reported that the patient is currently on 10mg of nadolol.The patient's mother declined a replacement however the patient's mother said they would switch the flex adapter.The patient's doctor stated the burn was an electrical burn.The patient's skin was cleaned with warm water, mild soap each time the electrdoe was changed.
Additional Manufacturer Narrative
It was reported that the patient had a burn on their skin that looked like the c6 sensor.The device was not returned for investigation.Engineering evaluation was unable to be performed on the patch as it is single use and was not returned.Allegation is confirmed through images of patient skin irritation attached to this case and is most probable to be a bio-incompatibility issue with the electrode adhesive and/or hydrogel pads.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: C6 MCOT PPM
• 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: 19416041
• Report Number: 2133409-2024-00032
• Device Sequence Number: 3239684
• Product Code: DSI
• UDI-Device Identifier: B146PE20
• UDI-Public: +B146PE20/$$0525P202444/Q1+
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: 02-01609
• Device Lot Number: P202444
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 08/28/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 13 MO
• Patient Sex: Female