BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXION

    MDR report key: 23447096 · Received November 3, 2025

    Report

    Report Number
    MW5178444
    Event Type
    Injury
    Date Received
    November 3, 2025
    Date of Event
    May 1, 2023
    Report Date
    October 29, 2025
    Manufacturer
    BTL INDUSTRIES JSC
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    RF MICRONEEDLING. LEFT ME WITH SIGNIFICANT FAT LOSS IN MY FACE RESULTING IN MAKING ME LOOK ABOUT 10-15 YEARS OLDER. ALSO LEFT ME WITH TERRIBLE GRID MARKS THAT TOOK MONTHS TO GO AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224893 EXION ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BTL INDUSTRIES JSC

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other