BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMSCULPT NEO

    MDR report key: 17218742 · Received June 27, 2023

    Report

    Report Number
    MW5118893
    Event Type
    Injury
    Date Received
    June 27, 2023
    Date of Event
    June 9, 2023
    Report Date
    June 24, 2023
    Manufacturer
    BTL INDUSTRIES JSC
    Product Code
    NGX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    EMSCULPT NEO ON QUADS NOW HAVE A HARD LUMP ON EACH QUAD WHERE APPLICATOR WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321077 EMSCULPT NEO STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING NGX BTL INDUSTRIES JSC

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female