BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPUS SYSTEM

    MDR report key: 23609522 · Received November 20, 2025

    Report

    Report Number
    3004450661-2025-00023
    Event Type
    Injury
    Date Received
    November 20, 2025
    Report Date
    November 20, 2025
    Manufacturer
    ALMA LASERS LTD.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FOLLOWING USE OF THE OPUS SYSTEM AT A USER FACILITY, A PATIENT EXPERIENCED HYPERPIGMENTATION AND SWELLING AT THE TREATMENT SITE. INVESTIGATION BY ALMA LASERS INC. FOUND THAT THE PATIENT MAY HAVE PROLONGED POST-INFLAMMATORY HYPERPIGMENTATION. ALMA LASERS INC. ATTEMPTED TO FOLLOW UP ON PATIENT'S HEALING PROGRESS BUT RECEIVED NO RESPONSE FROM THE USER FACILITY, THEREFORE THIS INCIDENT IS BEING REPORTED IN GOOD FAITH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314325 OPUS SYSTEM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ALMA LASERS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other