BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THUNDER MT

    MDR report key: 18786854 · Received February 27, 2024

    Report

    Report Number
    3004378299-2024-00003
    Event Type
    Injury
    Date Received
    February 27, 2024
    Date of Event
    February 19, 2024
    Report Date
    February 27, 2024
    Manufacturer
    QUANTA SYSTEM S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K171711
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LASER GOT ON FIRE. AN INVESTIGATION HAS BEEN OPENED TO OBTAIN MORE INFORMATION ABOUT THE EVENT DYNAMICS.

    Description of Event or Problem · 0

    LASER GOT ON FIRE. AN INVESTIGATION HAS BEEN OPENED TO OBTAIN MORE INFORMATION ABOUT THE EVENT DYNAMICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1669541 THUNDER MT SURGICAL LASER GEX QUANTA SYSTEM S.P.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown