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 Codes	Rash (2033); Skin Inflammation/ Irritation (4545)
Date of Event	09/11/2026
Type of Reportable Event	Serious Injury

• 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: 50859366
• Report Number: 2133409-2026-00210
• Device Sequence Number: 9498364
• Product Code: DRX
• UDI-Device Identifier: B146PE20
• UDI-Public: +B146PE20/$$1027E649755/Q15
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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 Catalogue Number: 02-01609
• Device Lot Number: E649755
• 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: 09/11/2026
• Initial Report FDA Received Date: 09/22/2026
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female