BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 22926128 · Received August 29, 2025

    Report

    Report Number
    3031944951-2025-00004
    Event Type
    Injury
    Date Received
    August 29, 2025
    Date of Event
    April 1, 2025
    Report Date
    August 29, 2025
    Manufacturer
    ROHRER AESTHETICS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NOT ENOUGH INFORMATION TO FULLY INVESTIGATE THIS CLAIM. THE INITIAL REPORTER ASKED TO REMAIN CONFIDENTIAL SO THERE WERE NO IDENTIFIERS THAT WOULD ENABLE US TO FIND A USER FACILITY THAT USED A DEVICE TO CAUSE THIS INJURY. ROHRER AESTHETICS SEARCHED OUR DATABASE OF COMPLAINTS AND HAD NO OTHER CLAIM OF A BAD BURN IN A VAGINA.

    Description of Event or Problem · 0

    ON JULY 30, 2025 FDA NOTIFIED ROHRER AESTHETICS, INC. OF A VOLUNTARY REPORT BY A PATIENT, REPORT NUMBER MW5172797. PATIENT CLAIMS THAT SHE GOT A VERY BAD BURN IN HER VAGINE FROM A CO2 LASER FROM HER PRIMARY CARE DOCUTOR'S OFFICE. SHE STATES THAT SHE COULD BARELY WALK AND WENT TO THE EMERGENCY ROOM WHERE SHE WAS GIVEN BURN CREAM AND PAIN MEDICATION. AFTER 3 MONTHS SHE IS STILL HAVING PROBLEMS WITH PAIN IN HER VAGINA AND NOT SURE IF SHE IS HEALED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2130811 UNKNOWN UNKNOWN GEX ROHRER AESTHETICS, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention