BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSO

    MDR report key: 24413972 · Received February 23, 2026

    Report

    Report Number
    MW5184202
    Event Type
    Injury
    Date Received
    February 23, 2026
    Date of Event
    February 16, 2026
    Report Date
    February 16, 2026
    Manufacturer
    HINGE HEALTH INC.
    Product Code
    NUH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472305 ENSO STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER NUH HINGE HEALTH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female MAGNESIUM.| OLMESARTAN.| PROBIOTIC.| PROPRANOLOL.