BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOENIX CO2

    MDR report key: 15180283 · Received August 5, 2022

    Report

    Report Number
    3011593504-2022-00001
    Event Type
    Injury
    Date Received
    August 5, 2022
    Date of Event
    June 21, 2022
    Report Date
    July 20, 2022
    Manufacturer
    ROHRER AESTHETICS
    Product Code
    GEX
    UDI-DI
    00860564000324
    PMA / PMN Number
    K110434
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A ROHRER CUSTOMER INCORRECTLY TREATED A PATIENT WITH A CO2 DEVICE CAUSING 3RD DEGREE BURNS TO THE PATIENT. THE CUSTOMER HAD NOT RECEIVED ANY TRAINING FOR THE DEVICE. HOWEVER, THE CUSTOMER DECIDED TO TREAT A PATIENT WITHOUT TRAINING OF THE DEVICE. THE PATIENT WAS ADMITTED TO THE BURN UNIT 2 DAYS AFTER THE ADVERSE EVENT. OUR SERVICE ENGINEER INSPECTED THE DEVICE ON (B)(6) 2022 AND FOUND THE DEVICE TO BE IN COMPLETE WORKING ORDER. THE LASER MET ALL CALIBRATION AND POWER STANDARDS AS SET BY THE FDA. THE CUSTOMER HAS NOT BEEN FORTHCOMING WITH DETAILS OF THE PATIENT. I WAS ONLY ABLE TO ASCERTAIN BACKGROUND AND ETHNICITY FROM PICTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287742 PHOENIX CO2 PHOENIX CO2 GEX ROHRER AESTHETICS Phoenix 00860564000324

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| S