BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMIRO S1 FACIAL RF SKIN TIGHTENING DEVICE

    MDR report key: 17949790 · Received October 16, 2023

    Report

    Report Number
    MW5147044
    Event Type
    Injury
    Date Received
    October 16, 2023
    Date of Event
    September 24, 2023
    Report Date
    October 10, 2023
    Manufacturer
    UNKNOWN
    Product Code
    PAY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I BOUGHT AN $699 RF(RADIO FREQUENCY) DEVICE ONLINE. (HTTPS://AMIROBEAUTY.COM/PRODUCTS/AMIROS1-GOLDEN-DOT-MATRIX-RF-SKIN-TIGHTENINGMACHINE?GCLID=CJ0KCQJW7JOPBHCFARISAL3BOBE1OOVOAJWGUNJX3NQL4PIYEK9ZUDTZFHCIWFFCG2PGPODWMXQRLNMAAS4MEALW_WCB), AND THEN I NOTICED A LOT OF ARTICLES DISCUSSING THE SAFETY CONCERNS OF THIS DEVICE. SOME PEOPLE SAID THEIR SKIN WAS HURT BY THE DEVICE. THEN I FOUND OUT IT IS NOT FDA CLEARED, ACCORDING TO THE RULES, A RF DEVICE MUST BE FDA CLEARED TO MARKET AND SALE IN THE STATES. I CONTACTED THE MERCHANT, THEY DON'T KNOW ABOUT THIS RULE AT ALL. THEY STATED THEY ARE CE CLEARED, AND BECAUSE THEY DON'T HAVE INTERNATIONAL WAREHOUSE, THEY CAN'T PERFORM RETURNS FOR ME. THIS IS JUST RIDICULOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82805 AMIRO S1 FACIAL RF SKIN TIGHTENING DEVICE OVER-THE-COUNTER RADIOFREQUENCY COAGULATION DEVICE FOR WRINKLE REDUCTION PAY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O