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

Model Number	02-01609
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Superficial (First Degree) Burn (2685); Skin Inflammation/ Irritation (4545)
Date of Event	07/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2024 the patient was burned by the c6 sensor while they were sleeping.The patient reported that the sensor electrocuted and "severely" burned them.The patient reported that there was a burn on their chest in the shape of the sensor.The patient detailed that the burn was painful, very red and open sore and raw.Due to the burn the patient went to the urgent care.It is unclear if they burn was treated with any medication.This report is related to 133409-2024-00052.
Additional Manufacturer Narrative
It was reported the patient experienced a burn that caused raw, very painful open sores on their chest under the universal patch.The universal patch or mcot sensor was not returned for device evaluation.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 components.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 driv; suite 150; eagan, MN 55121
• MDR Report Key: 20055073
• Report Number: 2133409-2024-00053
• Device Sequence Number: 8118161
• Product Code: DSI
• UDI-Device Identifier: B146PE20
• UDI-Public: +B146PE20/$$1025U602909/Q19
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 11/08/2024

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: U602909
• 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: 07/27/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female