BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CO2 LASER ( I DO NOT KNOW THE BRAND NAME)

    MDR report key: 22524250 · Received July 16, 2025

    Report

    Report Number
    MW5172797
    Event Type
    Injury
    Date Received
    July 16, 2025
    Date of Event
    April 1, 2025
    Report Date
    July 11, 2025
    Manufacturer
    ROHRER AESTHETICS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS TREATED WITH A CO2 LASER FOR VAGINAL ATROPHY AND GOT A VERY BAD BURN IN MY VAGINA. I HAD THE TREATMENT AT MY PRIMARY CARE DOCTOR'S OFFICE. I COULD BARELY WALK AFTER THE TREATMENT AND WENT TO THE EMERGENCY ROOM WHERE I WAS GIVEN BURN CREAM AND PAIN MEDICATION. IT HAS BEEN 3 MONTHS NOW AND I AM STILL HAVING PROBLEMS WITH PAIN IN MY VAGINA AND I AM NOT SURE IF I AM HEALED FULLY YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1771241 CO2 LASER ( I DO NOT KNOW THE BRAND NAME) POWERED LASER SURGICAL INSTRUMENT GEX ROHRER AESTHETICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention