BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGEND PRO

    MDR report key: 11702056 · Received April 21, 2021

    Report

    Report Number
    1720381-2021-00002
    Event Type
    Injury
    Date Received
    April 21, 2021
    Date of Event
    March 23, 2021
    Report Date
    April 21, 2021
    Manufacturer
    POLLOGEN LTD
    Product Code
    GEI
    UDI-DI
    07290016586138
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED BURNS FOLLOWING TREATMENT BY LEGEND PRO DEVICE. DESCRIBED HEAT AS BEING HOTTER THAN A SUNBURN AND WAS IN PAIN. ADVISED CLIENT TO PUT ICE. PATIENT WAS VERY PINK AND SWOLLEN AND SHOWED SIGNS OF A SEVERE HISTAMINE RESPONSE AND POSSIBLE ALLERGIC REACTION. THE CUSTOMER SPOKE TO THE PATIENT EVERY DAY DURING WEEK MONDAY - FRIDAY. ON FRIDAY IT WAS STILL SWOLLEN AND WAS EXPERIENCING ITCHINESS AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599324 LEGEND PRO ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES, PRODUCT CODE:GEI GEI POLLOGEN LTD LEGEND PRO 07290016586138

    Patients

    Seq Age Sex Outcome Treatment
    1 Other