BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATINUMLED THERAPY LIGHTS: BIOMAX 900

    MDR report key: 15563090 · Received October 6, 2022

    Report

    Report Number
    MW5112499
    Event Type
    Injury
    Date Received
    October 6, 2022
    Date of Event
    February 13, 2022
    Report Date
    October 5, 2022
    Manufacturer
    PLATINUM LED HOLDINGS LLC.
    Product Code
    ILY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PURCHASED A BIOMAX 900 RED LIGHT THERAPY DEVICE FROM PLATINUM LED THERAPY AT PLATINUMTHERAPYLIGHTS.COM, WHICH ON THEIR SITE IS ADVERTISED AS AN FDA-APPROVED CLASS 2 MEDICAL DEVICE. I REVIEWED THE INSTRUCTIONS CAREFULLY PRIOR TO USING THE DEVICE, AND FOLLOWED THE COMPANY'S INSTRUCTIONS REGARDING HOW FAR AWAY TO STAND AND HOW LONG TO USE THE DEVICE (ACTUALLY, I USED IT FOR EVEN LESS TIME THAN WAS SUGGESTED). THE THIRD TIME I USED THE DEVICE (OVER THE COURSE OF TWO WEEKS) IT CAUSED THE SKIN ON MY FACE TO BLISTER. I AM VERY CONCERNED THAT USING THE DEVICE EVEN MORE CONSERVATIVELY THAN THE COMPANY SUGGESTED CAUSED SKIN DAMAGE WHEN RED LIGHT IS SUPPOSED TO SAFE AND HEALTHY. I NOTIFIED THE COMPANY OF THIS SIDE EFFECT, AND THEY TOLD ME THEIR LIGHT IS SAFE WHEN USED CORRECTLY. THEY THEN TOLD ME TO STAND MUCH FURTHER AWAY FROM THE LIGHT. I POINTED OUT THIS DID NOT ALIGN WITH THEIR INSTRUCTIONS FOR USE AND ASKED WHY THEY MADE SUCH A POWERFUL LIGHT (AND ADVERTISE IT AS BEING "BETTER" THAN LIGHTS WITH LESS POWER) IF IT'S IN FACT DANGEROUS TO USE AS DIRECTED, BUT GOT NO RESPONSE. I TOOK A PHOTO OF ONE OF THE BLISTERS UNDER MY EYE THAT THIS CAUSED AND AM HAPPY TO SUBMIT IT IF NEEDED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2897342 PLATINUMLED THERAPY LIGHTS: BIOMAX 900 LAMP, INFRARED, THERAPEUTIC HEATING ILY PLATINUM LED HOLDINGS LLC. BIOMAX 900

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female CHLOROPHYLL| CYMBALTA| MCT OIL| MULTIVITAMIN | TRAZODONE| TURMERIC