MAUDE Adverse Event Report: Braemar Manufacturing, LLC BTP-1000L-2; Electrode - Adapter - Lead Wire

Model Number	02-00139
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Rash (2033); Skin Inflammation/ Irritation (4545)
Date of Event	09/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2026 that the patient was experiencing skin irritation while wearing the electrode - adapter - lead wire with electrode - pad - foam - vermed a10091.The patient described experiencing general redness and red bumps where the patch was applied.The patient did seek medical attention and was prescribed a topical steroid.The patient took a break in service due to the skin irritation.The patient did follow the recommended skin preparation.The patient had a history of skin sensitivity and allergy to latex.No further information to provide.
Additional Manufacturer Narrative
It was reported that the patient experienced a skin irritation while wearing the electrode - adapter - lead wire with electrode - pad - foam - vermed a10091.The electrode was unable to be inspected because it was not returned.Allegation should be considered confirmed as there are images of the patient's skin irritation and/or evidence the patient sought medical care to treat the skin irritation.The associated skin irritation is likely related to the patient reacting to the electrode adhesive and/or hydrogel.The following factor(s) were identified as having contributed to the skin irritation: intrinsic factors - known medical/dermatologic conditions.Medical adhesive related skin injury (marsi) is likely related to a biocompatibility hazard manifesting at the electrode's interface with the patient's skin.Patient reactions, such as skin irritation, resulting from biocompatibility issues are considered and assessed.Additionally, instructions for use (ifu) and patient education guides (peg) provide patients with guidance should skin irritation develop.

• Brand Name: BTP-1000L-2
• Common Device Name: Electrode - Adapter - Lead Wire
• 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: 50882702
• Report Number: 2133409-2026-00211
• Device Sequence Number: 21288802
• Product Code: IKD
• UDI-Device Identifier: B146PE20
• UDI-Public: +B146PE20/$$1027E649755/Q15
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153473
• 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): 09/24/2026

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: 02-00139
• Device Catalogue Number: 02-00139
• 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: 09/12/2026
• Initial Report FDA Received Date: 09/24/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Electrode - Pad - Foam - Vermed A10091.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 YR
• Patient Sex: Male