ENSO 3

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. FOLLOW-UP ATTEMPTS ARE CURRENTLY IN PROGRESS TO OBTAIN THE DEVICE FROM THE USER FOR EVALUATION.

Description of Event or Problem

USER REPORTED THEY USED THEIR ENSO M3 DEVICE TO ALLEVIATE THEIR LOWER BACK, SCIATICA PAIN. ON (B)(6) 2025, USER USED THEIR DEVICE FOR TWO CONSECUTIVE SESSIONS. USER REPORTED BURN ON (B)(6) 2025 AND THAT THEY DID NOT IMMEDIATELY FEEL THE BURN UNTIL THEY LAID DOWN. USER SOUGHT OUT MEDICAL ATTENTION AND RECEIVED A PRESCRIPTION MEDICATION FOR THEIR BURN. USER ALSO REPORTED THE GEL PADS USED WERE LOSING ADHESION. DEVICE AND GEL PAD WERE REQUESTED TO BE RETURNED TO CONDUCT FURTHER INVESTIGATION. MANUFACTURER NARRATIVE: A PRE-PAID LABEL HAS BEEN SENT TO THE REPORTER TO INITIATE A RETURN OF THE SUSPECTED DEVICE FOR FURTHER INVESTIGATION. SINCE THE DEVICE HAS NOT BEEN RETURNED, A FINAL ROOT CAUSE FOR THE REPORTED INCIDENT HAS NOT YET BEEN DETERMINED. REVIEW OF MANUFACTURING RECORDS AND USER'S SESSION ACTIVITY DOES NOT SHOW INDICATION OF A DEVICE MALFUNCTION. BASED ON AN INITIAL ASSESSMENT OF THE INCIDENT AND CONFIRMED BURNS BY THE USER, THIS REPORT IS BEING FILED. THE ENSO M3 USER MANUAL STATES, "IN RARE CASES, YOU MAY EXPERIENCE SKIN IRRITATION OR BURNS BENEATH A GEL PAD APPLIED TO YOUR SKIN. IF YOU EXPERIENCE AN ADVERSE REACTION, PLEASE STOP USING THE DEVICE AND CONSULT YOUR PHYSICIAN." THIS PROCESS WAS FOLLOWED APPROPRIATELY AND THE USER REPORTED THE ISSUE TO HINGE HEALTH. HINGE HEALTH HAS FOLLOWED UP WITH THE MEMBER FOR UPDATES ON THE USER'S CONDITION.

Additional Manufacturer Narrative

FOLLOW-UP #1: DEVICE WAS RETURNED FOR FURTHER INVESTIGATION. GEL PAD WEAR DOES NOT HAVE EXPOSED ELECTRICAL TRACES OR WEAR THAT WOULD POTENTIALLY CAUSE A BURN. ADDITIONALLY, REVIEWED BURN IMAGES SHOWS BURN SURFACE AREA LARGER THAN DEVICE GEL PADS. DEVICE INVESTIGATION SHOWS DEVICE DID NOT MALFUNCTION.

Description of Event or Problem

USER REPORTED THEY USED THEIR ENSO M3 DEVICE TO ALLEVIATE THEIR LOWER BACK, SCIATICA PAIN. ON (B)(6) 2025, USER USED THEIR DEVICE FOR TWO CONSECUTIVE SESSIONS. USER REPORTED BURN ON (B)(6) 2025 AND THAT THEY DID NOT IMMEDIATELY FEEL THE BURN UNTIL THEY LAID DOWN. USER SOUGHT OUT MEDICAL ATTENTION AND RECEIVED A PRESCRIPTION MEDICATION FOR THEIR BURN. USER ALSO REPORTED THE GEL PADS USED WERE LOSING ADHESION. DEVICE AND GEL PAD WERE REQUESTED TO BE RETURNED TO CONDUCT FURTHER INVESTIGATION. MANUFACTURER NARRATIVE: A PRE-PAID LABEL HAS BEEN SENT TO THE REPORTER TO INITIATE A RETURN OF THE SUSPECTED DEVICE FOR FURTHER INVESTIGATION. SINCE THE DEVICE HAS NOT BEEN RETURNED, A FINAL ROOT CAUSE FOR THE REPORTED INCIDENT HAS NOT YET BEEN DETERMINED. REVIEW OF MANUFACTURING RECORDS AND USER'S SESSION ACTIVITY DOES NOT SHOW INDICATION OF A DEVICE MALFUNCTION. BASED ON AN INITIAL ASSESSMENT OF THE INCIDENT AND CONFIRMED BURNS BY THE USER, THIS REPORT IS BEING FILED. THE ENSO M3 USER MANUAL STATES, "IN RARE CASES, YOU MAY EXPERIENCE SKIN IRRITATION OR BURNS BENEATH A GEL PAD APPLIED TO YOUR SKIN. IF YOU EXPERIENCE AN ADVERSE REACTION, PLEASE STOP USING THE DEVICE AND CONSULT YOUR PHYSICIAN." THIS PROCESS WAS FOLLOWED APPROPRIATELY AND THE USER REPORTED THE ISSUE TO HINGE HEALTH. HINGE HEALTH HAS FOLLOWED-UP WITH THE MEMBER FOR UPDATES ON THE USER'S CONDITION.