EPATCH 2.5, BTH

Description of Event or Problem

ON (B)(6) 2026, THE PATIENT REPORTED THAT THE EPATCH SENSOR ELECTROCUTED THE PATIENT, FLASHED RED, AND BECAME WARM/OVERHEATED WHILE BEING WORN. THE PATIENT WAS DRIVING AT THE TIME AND FELT A SENSATION TRAVELING FROM THE SHOULDER TO THE BICEP. NO MEDICAL ATTENTION WAS SOUGHT INITIALLY, AND NO MEDICATION WAS TAKEN. THE PATIENT REPORTED THAT SYMPTOMS IMPROVED AFTER REMOVING THE DEVICE. NO MOISTURE EXPOSURE, VISIBLE SKIN MARKS, OR UNUSUAL APPEARANCE OF THE PATCH WERE NOTED AFTER REMOVAL. THE PATIENT LATER REPORTED EXPERIENCING SPASMS AND SOUGHT MEDICAL EVALUATION. THE PATIENT'S SPOUSE RESEARCHED THE DEVICE AND MENTIONED AN ON/OFF BUTTON ON THE SENSOR. THE PATIENT STATED THAT NO SIMILAR SYMPTOMS HAD BEEN EXPERIENCED BEFORE THE ALLEGED MALFUNCTION. FOLLOW-UP REPORT RECEIVED ON 30 APRIL 2026 STATED THAT THE PATIENT CONTINUED TO EXPERIENCE SPASMS, WITH THE MOST SEVERE OCCURRING THREE DAYS EARLIER. THE PATIENT DESCRIBED TWITCHING SENSATIONS EXTENDING FROM UNDER THE RIB AREA TO THE ABDOMEN AND LEGS, ALONG WITH FREQUENT BATHROOM USE. THE PATIENT REPORTED THAT THE PATCH HAD FOLDED OVER AND STUCK TO THE DEVICE, AND THAT THE ADHESIVE APPEARED MELTED, FLEXIBLE, AND FLOPPY. AFTER REMOVAL, AN OUTLINE OF THE PATCH WAS VISIBLE ON THE SKIN AND APPEARED LIGHTER THAN THE SURROUNDING AREA. A BURNING SENSATION ALSO DEVELOPED IN THE AFFECTED AREA. THE PATIENT STATED THAT THE SENSOR CAUSED PAIN, DISPLAYED A SOLID RED LIGHT, AND APPEARED TO MALFUNCTION. AN ATTORNEY CONTACTED (B)(6) ON 12 MAY 2026 REGARDING THE RETURNED DEVICE, WHICH HAD BEEN RECEIVED ON 27 APRIL 2026. CONFIRMATION OF RECEIPT WAS PROVIDED ON 13 MAY 2026. ADDITIONAL INFORMATION FROM THE ATTORNEY INDICATED THAT NO ISSUES WERE IDENTIFIED DURING THE PHYSICIAN EVALUATION AND THAT THE PATIENT'S SYMPTOMS HAD IMPROVED AFTER THE DEVICE HAD BEEN REMOVED FOR SEVERAL WEEKS. A LEGAL NOTICE DATED 10 JUNE 2026 WAS LATER RECEIVED, ALLEGING INJURIES RELATED TO THE EVENT AND INCLUDING SUPPORTING MEDICAL DOCUMENTATION. THE NOTICE STATED THAT THE PATIENT HAD REACHED MAXIMUM RECOVERY BUT CONTINUED TO EXPERIENCE RESIDUAL SPASMS AND DISCOMFORT. A CLAIM WAS MADE FOR LOSS OF CONSORTIUM, PAIN AND SUFFERING, INCONVENIENCE OF DAILY LIFE, AND FUTURE PAIN AND SUFFERING.