BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVOLOGI LUMNEN

    MDR report key: 23995398 · Received January 7, 2026

    Report

    Report Number
    MW5181926
    Event Type
    Injury
    Date Received
    January 7, 2026
    Date of Event
    November 17, 2025
    Report Date
    December 17, 2025
    Manufacturer
    PREMIER DEAD SEA COSMETIC LABORATORIES LTD.
    Product Code
    OHS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PURCHASED LUMNEN LASER PRODUCT ON (B)(6) 2025 FOR $10,471.20 FROM (B)(6) FROM FORMIDABLESS BEAUTY. I ALSO BOUGHT OTHER COSMETIC PRODUCTS FOR $314.14. THE PHONE NUMBER IS (B)(6) ON RECEIPT. ON (B)(6) 2025, I REPORTED/ TESTED PROBLEMS TO (B)(6) AND ASKED HIM TO "CLARIFY INSTRUCTIONS ABOUT APPLICATION AND USAGE." HIS REPLY DID NOT SPECIFY NAME OF PRODUCT(S) ON (B)(6) 2025; I TESTED (B)(6) "THAT LASER PRODUCT WAS TOO HOT ON MY FACE. COULD HEAT BE ADJUSTED?" AFTER COUPLE DAYS OF USE, (B)(6) SAID TO STOP USING PRODUCTS. ON (B)(6) 2025 REPORT FROM URGENTCARE: "RASH, SEVERE ITCHING, PIMPLE, REDNESS, SWELLING AROUND EYES ASSOCIATED WITH COSMETICS." "IRRITANT CONTACT DERMATITIS DUE TO COSMETICS." I RETURNED PRODUCTS TO MOANA CRYSTALS AND BEAUTY BECAUSE THE EXPO BOOTH WAS REGISTERED TO THEM. ALSO, (B)(6) HAD ASKED ME TO MEET HIM AT (B)(6) FOR A COMPLIMENTARY VIP TREATMENT. I WAS GIVEN A "PRODUCT EXCHANGE / REFUND REQUEST FORM" WHICH I COMPLETED AND ATTACHED DOCTOR'S REPORT. ON (B)(6) 2025, I SENT THE REFUND REQUEST FORM AND DOCTOR'S REPORT USING CERTIFIED MAIL TO (B)(4). BUT THEY "REFUND AND RETURN MY MAIL." THEY ALSO MAILED A BOX TO ME; I ASSUME IT CONTAINED ALL THE PRODUCTS I HAD PURCHASED. I "REFUND THE BOX" AND SENT BOX BACK. (B)(6) / FOR MIDABLESS. THEY HAVE ALL THE PRODUCTS. I CONTACTED THE OFFICE "AVOLOGI.COM" WHERE I REGISTERED THE LUMNEN LASER PRODUCT. I WAS TOLD TO CONTACT THE LOCATION WHERE I MADE THE PURCHASE SINCE EACH LOCATION IS INDEPENDENTLY OWNED AND OPERATED. ONLINE: FORMIDABLESS.COM, WEBSITE: (B)(6). EXPO BOOTH WAS REGISTERED BY (B)(6); EXPO RECEIPTS: FORMIDABLESS, PHONE (B)(6), ITEMS WERE NOT ITEMIZED ON RECEIPTS ($10,471.20, $314.14) I DON'T KNOW NAMES OF COSMETIC PRODUCTS. I RETURNED THEM AND ASKED FOR REFUND. WRINKLES, BAGS UNDER EYES, SAGGY SKIN, LIFT AND REMOVE FACIAL LINES AND STRETCH MARKS. REJUVENATE SKIN. REGISTERED PRODUCT WITH (B)(6): (B)(4). LUMNEN - FIRST FDA CERTIFIED BIO-STIMULATOR AND OTHER COSMETIC. HAWAII MARKET EXPO; INTERNATIONAL CONVENTION SERVICES, FORMIDABLESS BEAUTY, (B)(6) (ADDRESS ON BOX FROM FORMIDABLESS), (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61423 AVOLOGI LUMNEN LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION OHS PREMIER DEAD SEA COSMETIC LABORATORIES LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Disability B12| DESONIDE CREAM | DILTIAZEM | ESCITILOPRAM| FORMIDABLESS 24K NON-SURGICAL FACELIFT SYSTEM FACELIFT CREAM| FORMIDABLESS 24K NON-SURGICAL FACELIFT SYSTEM FACELIFT MASK| FORMIDABLESS 24K NON-SURGICAL FACELIFT SYSTEM FACELIFT SERUM| FORMIDABLESS DAYTIME COLLAGEN CREAM| FORMIDABLESS EVENING PEPTIDE CREAM| FORMIDABLESS NON-SURGICAL EYE SOLUTION (EYE LIFT)| FORMIDABLESS SUPER HYDRATING EYE SERUM| LEVOTHYROXINE | MIRABEGRON| MONTELUKAST