ENSO M3

Additional Manufacturer Narrative

FOLLOW-UP #1 FROM REPORT MW5184202: INVESTIGATION OF THIS REPORTED ADVERSE EVENT SHOWS THE DEVICE DID NOT MALFUNCTION. REVIEW OF SESSION DATA DEMONSTRATED NO ABNORMAL DEVICE ACTIVITY. MANUFACTURING RECORD REVIEW CONFIRMED NO FAILURES OR DEVIATIONS RELATED TO THE UNIT IN QUESTION. THE USER REPORTED A SINGLE OCCURRENCE OF A "SHOCK" SENSATION DURING ENSO USE. THE USER CONFIRMED CORRECT USE AND PLACEMENT OF THE DEVICE AND GEL PAD. HINGE HEALTH INITIATED A FOLLOW-UP TO OBTAIN CLARIFICATION ON THE SEVERITY OF THE SENSATION AND TO DETERMINE IF MEDICAL ATTENTION WAS REQUIRED. THE USER DID NOT RESPOND TO THIS FOLLOW-UP INQUIRY. THE HARM RELATED TO ELECTRICAL SENSATION/SHOCK IS CLASSIFIED AS MINOR. THIS CLASSIFICATION IS BASED ON THE ASSESSMENT THAT THE POTENTIAL ADVERSE EVENT RESULTS IN TEMPORARY DISCOMFORT ONLY AND IS NOT EXPECTED TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR NECESSITATE MEDICAL INTERVENTION. BASED ON THE FINDINGS OF THIS INVESTIGATION THAT THE DEVICE FUNCTIONED AS INTENDED AND THE RESULTING HARM IS CLASSIFIED AS MINOR, THIS REPORTED ADVERSE EVENT WAS DETERMINED TO NOT BE REPORTABLE.

Description of Event or Problem

I HAVE BEEN USING THE ENSO DEVICE THROUGH HINGE HEALTH FOR ALMOST A YEAR. WHEN I WAS USING IT TODAY, ABOUT 10 MINUTES INTO USE, IT ELECTROCUTED ME.