MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC UNIT, EPATCH 2.0, BTH/ UNIVERSAL ELECTRODE-PATCH

Model Number	900-0632-00
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Biocompatibility (2886)
Health Effect - Clinical Codes	Blister (4537); Skin Inflammation/ Irritation (4545)
Date of Event	03/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient called stating patch has caused reaction - sore painful peeling skin.Noticed since day 1.The patient's skin was prepped with alcohol and patch replaced daily.Neosporin cream was used on skin.The patient is still currently wearing device.Skin sensitivity known prior to receiving device.Patient services called the patient 3 times obtain additional information and no answer.Additional information was provided on 12 april 2023 from patient services from the patient: the patient reported that they were prescribed hydrocortisone cream by their doctor.The patient could not recall the name of brand that was prescribed.
Additional Manufacturer Narrative
Engineering evaluation was unable to be performed as the electrode/device was not returned.Allegation is confirmed through images of patient skin irritation and 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: UNIT, EPATCH 2.0, BTH/ UNIVERSAL ELECTRODE-PATCH
• Common Device Name: UNIT, EPATCH 2.0, BTH/ UNIVERSAL ELECTRODE-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
• MDR Report Key: 16794976
• Report Number: 2133409-2023-00015
• Device Sequence Number: 3138904
• Product Code: DSI
• UDI-Device Identifier: B146EP020
• UDI-Public: B146EP020
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2023

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: 900-0632-00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 46 YR
• Patient Sex: Male