BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPLENDOR X

    MDR report key: 19151204 · Received April 22, 2024

    Report

    Report Number
    1720381-2024-00002
    Event Type
    Injury
    Date Received
    April 22, 2024
    Date of Event
    April 1, 2024
    Report Date
    April 22, 2024
    Manufacturer
    BIOS S.R.L.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FROM LUMENIS, ON (B)(6) 2024: "CX REPORTED DURING TREATMENT PATIENT WAS BURNED ON THE FACE IN BETWEEN THE EYEBROWS, BROKE HER SKIN OPEN AND MADE A HOLE IN THE SKIN. CX WAS USING THE CONSERVATIVE SETTING SINCE THE PATIENT HAS LIGHT SKIN. NO ERROR CODES NOR MESSAGE APPEARED. POSSIBLE HIGH ENERGY DURING TREATMENT. PHOTOS ATTACHED DURING THE ADVERSE EVENT."

    Additional Manufacturer Narrative · 0

    FROM LUMENIS, ON 09/04/2024: "CX REPORTED DURING TREATMENT PATIENT WAS BURNED ON THE FACE IN BETWEEN THE EYEBROWS, BROKE HER SKIN OPEN AND MADE A HOLE IN THE SKIN. CX WAS USING THE CONSERVATIVE SETTING SINCE THE PATIENT HAS LIGHT SKIN. NO ERROR CODES NOR MESSAGE APPEARED. POSSIBLE HIGH ENERGY DURING TREATMENT. PHOTOS ATTACHED DURING THE ADVERSE EVENT."

    Description of Event or Problem · 0

    FROM LUMENIS (DISTRIBUTOR IN THE US), ON (B)(6) 2024: "CX REPORTED DURING TREATMENT PATIENT WAS BURNED ON THE FACE IN BETWEEN THE EYEBROWS, BROKE HER SKIN OPEN AND MADE A HOLE IN THE SKIN. CX WAS USING THE CONSERVATIVE SETTING SINCE THE PATIENT HAS LIGHT SKIN. NO ERROR CODES NOR MESSAGE APPEARED. POSSIBLE HIGH ENERGY DURING TREATMENT. PHOTOS ATTACHED DURING THE ADVERSE EVENT."

    Description of Event or Problem · 0

    FROM LUMENIS (DISTRIBUTOR IN THE US), ON 09/04/2024: "CX REPORTED DURING TREATMENT PATIENT WAS BURNED ON THE FACE IN BETWEEN THE EYEBROWS, BROKE HER SKIN OPEN AND MADE A HOLE IN THE SKIN. CX WAS USING THE CONSERVATIVE SETTING SINCE THE PATIENT HAS LIGHT SKIN. NO ERROR CODES NOR MESSAGE APPEARED. POSSIBLE HIGH ENERGY DURING TREATMENT. PHOTOS ATTACHED DURING THE ADVERSE EVENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2259516 SPLENDOR X SPLENDOR X GEX BIOS S.R.L. GA-5000000

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Female Required Intervention