BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIRA PRO

    MDR report key: 19499215 · Received June 7, 2024

    Report

    Report Number
    MW5155996
    Event Type
    Injury
    Date Received
    June 7, 2024
    Date of Event
    May 15, 2024
    Report Date
    June 5, 2024
    Manufacturer
    NIRA INNOVATIONS INC.
    Product Code
    OHS
    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

    THE NIRA PRO IS FDA CLEARED AND IS A HAND-HELD, LASER DEVICE THAT IS SUPPOSED TO STIMULATE COLLAGEN AND GIVE A MORE YOUTHFUL APPEARANCE. I USED IT ONCE A DAY, CONSERVATIVELY AND SYMMETRICALLY, AND SAW NO CHANGE AFTER 3 MONTHS UNTIL I WOKE UP ON (B)(6) 2024 WITH BUMPS AND BULGES AND DARK, BRUISED-LOOKING AREAS. MY FACE WAS SORE AND LOOKED DISTORTED. I SAW MY DERMATOLOGIST ON AN EMERGENCY BASIS AND HE PRESCRIBED DOXYCYCLINE AND THE TOPICAL CREAM OPZELURA. TODAY IS THE 21ST DAY AND MY FACE HAS IMPROVED BUT HAS A WAY TO GO. I THINK THE NIRA PRO IS DANGEROUS AND SHOULD NOT BE SOLD TO THE PUBLIC. THIS NIRA PRO IS ADVERTISED ON-LINE. THE NIRASKIN.COM WEBSITE AND DEVICE INSERT DO NOT GIVE ANY INSTRUCTIONS OTHER THAN SAYING YOU CAN USE IT TWICE A DAY OR MORE, JUST NOT TWICE IN ONE HOUR. HOW CAN THEY SELL SUCH A DANGEROUS DEVICE THAT DAMAGES THE FACE WITH NO HELPFUL GUIDELINES OR INSTRUCTIONS?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184244 NIRA PRO LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION OHS NIRA INNOVATIONS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Other CHOLESTEROL.| DAILY VITAMINS.| ESTROGEN.| MED FOR BLOOD PRESSURE.| THYROID.| TYLENOL.