BTP-1000A

Additional Manufacturer Narrative

THE PATIENT REPORTED ON (B)(6) 2026 THEY EXPERIENCED GENERAL REDNESS AND ITCHING WHILE USING AN MCOT DEVICE WITH FLEXWIRE CONFIGURATION AND S&W ELECTRODES (LOT NUMBER 250922-0372). THE PATIENT REPORTED THAT THE REDNESS WAS NOT SEVERE AND THE ITCHING WAS NOT AS BAD. THE PATIENT SOUGHT MEDICAL TREATMENT AND WAS PRESCRIBED TRIAMCINOLONE, A TOPICAL ANTI-INFLAMMATORY CREAM. THE PATIENT HAS A HISTORY OF SKIN SENSITIVITY TO ADHESIVES AND FOLLOWED THE RECOMMENDED SKIN PREPARATION STEPS. ENGINEERING EVALUATION WAS UNABLE TO BE PERFORMED AS THE FLEX WIRE ADAPTER WAS NOT RETURNED. THE FLEX WIRE ADAPTER WHILE UTILIZING THE ELECTRODE - PAD - S&W 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 IS ELDERLY AND OVER 65 YEARS OLD AND HAS A HISTORY OF SKIN SENSITIVITY TO ADHESIVES. THE PRODUCT LABELING ADVISED PATIENT OF ALTERNATE OPTIONS AND OTHER STEPS TO TAKE IF SKIN IRRITATION DEVELOPS, INCLUDING HEALTHCARE PROFESSIONAL CONTACT AS NEEDED.

Description of Event or Problem

THE PATIENT REPORTED ON (B)(6) 2026 THEY EXPERIENCED GENERAL REDNESS AND ITCHING WHILE USING AN MCOT DEVICE WITH FLEXWIRE CONFIGURATION AND S&W ELECTRODES (LOT NUMBER 250922-0372). THE PATIENT REPORTED THAT THE REDNESS WAS NOT SEVERE AND THE ITCHING WAS NOT AS BAD. THE PATIENT SOUGHT MEDICAL TREATMENT AND WAS PRESCRIBED TRIAMCINOLONE, A TOPICAL ANTI-INFLAMMATORY CREAM. THE PATIENT HAS A HISTORY OF SKIN SENSITIVITY TO ADHESIVES AND FOLLOWED THE RECOMMENDED SKIN PREPARATION STEPS.