MAUDE Adverse Event Report: HINGE HEALTH ENSO 3; TENS

Model Number	ENSO M3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/20/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
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.
Event or Problem Description
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.

• Brand Name: ENSO 3
• Common Device Name: TENS
• Manufacturer (Section D): HINGE HEALTH; 455 market st. suite 700; san francisco CA 94105
• Manufacturer (Section G): HINGE HEALTH; 455 market st. suite 700; san francisco CA 94105
• Manufacturer Contact: charles han ; 455 market st. suite 700; san francisco, CA 94105 ; 8559022777
• MDR Report Key: 23992925
• Report Number: 3012640203-2025-00001
• Device Sequence Number: 10536328
• Product Code: NUH
• UDI-Device Identifier: 00850045950064
• UDI-Public: (01)00850045950064
• Combination Product (Y/N): N
• PMA/510(K) Number: K233784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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: ENSO M3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Female