BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATINUMLED BIOMAX 900

    MDR report key: 24998209 · Received April 27, 2026

    Report

    Report Number
    MW5187254
    Event Type
    Injury
    Date Received
    April 27, 2026
    Date of Event
    March 1, 2026
    Report Date
    April 20, 2026
    Manufacturer
    PLATINUM LED HOLDINGS LLC.
    Product Code
    ILY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I USED THE PLATINUMLED BIOMAX 900 AT A RESTORE HYPER WELLNESS LOCATION 1¿2 TIMES PER WEEK (COMPLETING 9 SESSIONS IN 5 WEEKS). THE PROTOCOL INVOLVED A HIGH-INTENSITY "SANDWICH" SETUP AT A 10-INCH DISTANCE FOR 13 MINUTES PER SESSION. I WAS UNABLE TO STAND FURTHER AWAY BECAUSE THE PANELS WERE PLACED CLOSE TOGETHER. SHORTLY AFTER AROUND WEEK 5, I NOTICED SIGNIFICANT AND PROGRESSIVE FACIAL VOLUME LOSS, VOLUME LOSS IN MY HANDS AND NECK. SPECIFICALLY HOLLOWING IN MY TEMPLES AND EYES AND DEFLATED SUNKEN CHEEKS. THIS ADIPOSE ATROPHY HAS CAUSED SUDDEN SKIN LAXITY AND A "SKELETALIZED" APPEARANCE. I ALSO DEVELOPED INTERMITTENT NUMBNESS ABOVE MY RIGHT EYEBROW. WHILE THERE WAS NO SURFACE BURNING, THE 1060NM WAVELENGTH (WHICH THE MANUFACTURER MARKETS FOR FAT REDUCTION) APPEARS TO HAVE TARGETED AND SHRUNKEN MY SUBCUTANEOUS FAT PADS IN MY FACE NECK AND HANDS. THIS DEVICE WAS USED ON MY FACE WITHOUT ANY WARNING OF UNINTENDED FAT LOSS OR LONG-TERM DISFIGUREMENT BY THE MEDSPA RESTORE HYPER WELLNESS. THIS ADVERSE SIDE EFFECT IS NOT MENTIONED ON THE PLATINUMLED WEBSITE NOR THE RESTORE HYPER WELLNESS WEBSITE OR "CONSENT" FORMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254193 PLATINUMLED BIOMAX 900 LAMP, INFRARED, THERAPEUTIC HEATING ILY PLATINUM LED HOLDINGS LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Other