BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIRA ANTI-AGING LASER DEVICE

    MDR report key: 20586460 · Received October 31, 2024

    Report

    Report Number
    MW5161997
    Event Type
    Injury
    Date Received
    October 31, 2024
    Report Date
    October 28, 2024
    Manufacturer
    NIRA INNOVATIONS INC.
    Product Code
    OHS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I BOUGHT A NIRA DEVICE. THIS IS HAND-HELD DEVICE THAT IS USED TO HELP WITH WRINKLES. APPROVED TO BE USED UNDER THE EYES AT THE TIME. NOT SURE ABOUT NOW. I USED THE DEVICE IN 2022. AFTER A FEW WEEKS OF USE UNDER MY EYES. I NOTICED THAT HAD A TREMENDOUS FAT LOSS UNDER MY EYES AND MY EYES LOOKED BRUISED. AFTER TWO YEARS THE DISCOLORATION DID NOT GO AWAY. ALSO, I USED THE DEVICE ON OTHER AREAS OF MY FACE. BUT IT CAUSED FAT LOSS ON THE AREAS TREATED. FOR EXAMPLE, I TREATED A CHICKEN POX SCAR WITH THE DEVICE. AFTER A FEW WEEKS I NOTICED DIFFERENCE IN UNEVENNESS BETWEEN AREAS TREATED AND NON-TREATED. THIS IS A TERRIBLE DEVICE. YOU MIGHT NOT NOTICE THE DAMAGE RIGHT AWAY. UNTIL YOU WAKE UP ONE DAY AND YOU SEE A VERY DRASTIC CHANGE ON YOUR SKIN. DO NOT GET THIS PRODUCT. WRINKLES (FACE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2188159 NIRA ANTI-AGING LASER DEVICE LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION OHS NIRA INNOVATIONS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female OMEGA 3.| TURMERIC.