MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC BTP-1000A; ELECTRODE - ADAPTER - FLEX

Model Number	02-00143
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	03/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported on (b)(6) 2026 skin irritation, rash, and blisters/welts associated with an patch device using flexwire configuration and vermed electrodes.The patient sought medical attention for the skin irritation and was prescribed nystatine and triamtinolone to treat the condition.Despite the irritation, the patient did not take a break in service.The patient did not follow the recommended skin preparation instructions and instead used alcohol to clean the area.The patient has a history of sensitive skin with a known allergy to betadine.The lot number of the adhesive that caused the irritation was not available.
Additional Manufacturer Narrative
The patient reported on (b)(6) 2026 skin irritation, rash, and blisters/welts associated with an patch device using flex wire configuration and vermed electrodes.The patient sought medical attention for the skin irritation and was prescribed nystatine and triamtinolone to treat the condition.Despite the irritation, the patient did not take a break in service.The patient did not follow the recommended skin preparation instructions and instead used alcohol to clean the area.The patient has a history of sensitive skin with a known allergy to betadine.The lot number of the adhesive that caused the irritation was not available.The flex wire adapter was not returned for evaluation.Engineering evaluation was unable to be performed as the flex wire adapter was not returned.The flex wire adapter while utilizing the electrode - pad - vermed electrode is single use and disposed after use; therefore, it is not likely to be returned.Any skin irritation is most probable to be a biocompatibility issue with the electrode adhesives.Medical adhesive related skin injury (marsi) is likely related to a biocompatibility hazard manifesting at the electrode's interface with the patient's skin.The following factors were identified and/or attributed to electrode skin irritation and associated symptoms.The patient used improper application techniques and used alcohol to clean the area.The patient also has a history of sensitive skin with a known allergy to betadine.The product labeling advised patient of alternate options and other steps to take if skin irritation develops, including healthcare professional contact as needed.

• Brand Name: BTP-1000A
• Common Device Name: ELECTRODE - ADAPTER - FLEX
• 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; siute 150; eagan MN 55121
• Manufacturer Contact: beverly okoh ; 1285 corporate center drive; siute 150; eagan, MN 55121
• MDR Report Key: 24740493
• Report Number: 2133409-2026-00056
• Device Sequence Number: 12220499
• Product Code: IKD
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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: 02-00143
• 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: Not provided
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ELECTRODE - PAD - FOAM - VERMED A10091
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female