BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVOLOGI ENEO TOTALE BLU

    MDR report key: 21606723 · Received March 14, 2025

    Report

    Report Number
    MW5167694
    Event Type
    Injury
    Date Received
    March 14, 2025
    Date of Event
    February 16, 2025
    Report Date
    May 8, 2025
    Manufacturer
    PREMIER DEAD SEA COSMETIC LABORATORIES LTD.
    Product Code
    OHS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    REPORTER PURCHASED THE AVOLOGI ENEO TOTALE BLUE WHILE OUT OF THE COUNTRY IN (B)(6), MEXICO. REASON FOR THE PURCHASE WAS TO TREAT THEIR ROSACEA. AFTER THE INITIAL USE OF THE PRODUCT IT WAS REPORTED THAT THEIR FACE STARTED TO BURN AND BECAME INFLAMED, WHICH LED THEM TO STOPPING USE IMMEDIATELY AND VISITING THE DERMATOLOGIST THE VERY NEXT DAY TO GET TREATMENT FOR HER SYMPTOMS. PATIENT BELIEVES THAT THIS IS A HARMFUL DEVICE AS WELL AS A SCAM AFTER FINDING MULTIPLE COMPLAINTS ABOUT PRODUCT DUE TO THEIR OWN RESEARCH. PATIENT ALSO REPORTED THAT THE DEVICE SHOWN TO HER AT THE STORE WHERE SHE MADE THE PURCHASE WAS NOT THE SAME DEVICE THAT SHE USED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 05/08/2025 FOR REPORT MW5167694. REPORTER WANTED TO CLARIFY THAT THE DEVICE DEMONSTRATED ON HER (SAMPLED ON HER) WAS NOT THE SAME AS THE ONE SHE PURCHASED TO TAKE HOME AND USE. SHE HAD NO REACTION TO DEVICE THAT WAS SAMPLED ON HER, BUT HAD THE SIGNIFICANT SKIN REACTION TO PRODUCT USED AT HOME. REPORTER STATES THAT THE DEVICE'S BOX STATES "FDA APPROVED AS A CLASS II MEDICAL DEVICE" AND "DERMATOLOGIST APPROVED". AFTER HER SKIN REACTION OCCURRED, THE REPORTER SAW A DERMATOLOGIST, WHO INSTRUCTED TO STOP USING THE DEVICE. REPORTER THEN STOPPED USING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824475 AVOLOGI ENEO TOTALE BLU LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION OHS PREMIER DEAD SEA COSMETIC LABORATORIES LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female