BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMSCULPT NEO

    MDR report key: 23907449 · Received December 29, 2025

    Report

    Report Number
    MW5181302
    Event Type
    Malfunction
    Date Received
    December 29, 2025
    Report Date
    December 19, 2025
    Manufacturer
    BTL INDUSTRIES JSC
    Product Code
    NGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    I WAS SOLD A MEDICAL DEVICE CALLED EMSCULPT NEO FROM A COMPANY NAMED (B)(4). THEIR SALESMEN WERE VERY PUSHY AND CLAIMED THAT THE MACHINE USE FOR MUSCULAR ACTIVATION AND FAT LOSS WAS THE EXACT EQUIVALENT TO 20,000 CRUNCHES IN 30 MINS. THE MACHINE DID NOT WORK AS CLAIMED AND THEY "PROMISE" THESE RESULTS. I HAVE TEXT MESSAGE PROOF WITH THE 20,000 CRUNCH STATEMENT WHICH IS OFF-LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2462265 EMSCULPT NEO STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING NGX BTL INDUSTRIES JSC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown