BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONALISA TOUCH

    MDR report key: 17799262 · Received September 21, 2023

    Report

    Report Number
    MW5146036
    Event Type
    Malfunction
    Date Received
    September 21, 2023
    Date of Event
    July 2, 2020
    Report Date
    September 19, 2023
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING SPA
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I EXPERIENCED LOTS OF BLEEDING. I HAD BURNS ON MY CERVIX. I ALSO HAVE A SCAR ON LIVER. DOCTOR ALSO FORGOT TO HAVE ME WEAR PROTECTIVE EYE GLASSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1500533 MONALISA TOUCH POWERED LASER SURGICAL INSTRUMENT GEX EL.EN. ELECTRONIC ENGINEERING SPA MONALISA TOUCH

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Other