MAUDE Adverse Event Report: HINGE HEALTH ENSO M3; TENS

Model Number	ENSO M3
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	02/16/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
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.

• Brand Name: ENSO M3
• Common Device Name: TENS
• Manufacturer (Section D): HINGE HEALTH; 455 market st. suite 700; san francisco 94105
• Manufacturer Contact: charles han ; 455 market, suite 700; san francisco, CA 94105 ; 8559022777
• MDR Report Key: 24760721
• Report Number: 3012640203-2026-00001
• Device Sequence Number: 15745404
• Product Code: NUH
• UDI-Device Identifier: 00850045950064
• UDI-Public: (01)00850045950064
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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
• 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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MAGNESIUM.OLMESARTAN.PROBIOTIC.PROPRANOLOL.
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White