BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYBRID SYSTEM 70W 120V 50/60 HZ

    MDR report key: 23752605 · Received December 8, 2025

    Report

    Report Number
    3004450661-2025-00025
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    October 30, 2025
    Report Date
    December 8, 2025
    Manufacturer
    ALMA LASERS LTD.
    Product Code
    GEX
    UDI-DI
    17290110122109
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    HI, US
    Reporter Occupation
    117

    Narratives

    Description of Event or Problem · 0

    FOLLOWING USE OF THE HYBRID SYSTEM AT A USER FACILITY, A PATIENT EXPERIENCED A BURN AT THE TREATMENT SITE. INVESTIGATION BY ALMA LASERS INC. FOUND THAT THE BURN WILL LIKELY LEAVE A PERMANENT SCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2113756 HYBRID SYSTEM 70W 120V 50/60 HZ POWERED LASER SURGICAL INSTRUMENT GEX ALMA LASERS LTD. 1 17290110122109

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Other