BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAR IRON

    MDR report key: 21701319 · Received March 26, 2025

    Report

    Report Number
    MW5168293
    Event Type
    Malfunction
    Date Received
    March 26, 2025
    Date of Event
    March 21, 2025
    Report Date
    March 22, 2025
    Manufacturer
    UNKNOWN
    Product Code
    NZF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PURCHASED A DEVICE CALLED "FAT IRON ¿ CELLULITE REDUCING & BODY TONING DEVICE" THROUGH GROUPON ON. THE PRODUCT WAS ADVERTISED USING CLAIMS THAT IMPLIED FDA APPROVAL OR CLEARANCE FOR FAT REDUCTION AND SKIN TIGHTENING. HOWEVER, AFTER RECEIVING THE DEVICE AND RESEARCHING ITS LEGITIMACY, I FOUND IT TO BE A GENERIC, UNBRANDED ITEM THAT DOES NOT APPEAR IN THE FDA 510(K) DATABASE. THE DEVICE LACKS ANY CLEAR SAFETY LABELING, FDA REGISTRATION, OR VERIFIABLE MANUFACTURER DETAILS. IT ALSO DOES NOT INCLUDE EMS PRONGS OR FEATURES SHOWN IN THE PRODUCT IMAGES ON THE GROUPON SITE. DESPITE REPEATED ATTEMPTS, I WAS UNABLE TO CONTACT THE VENDOR FOR CLARIFICATION. I BELIEVE THIS PRODUCT CONSTITUTES FALSE ADVERTISING AND POSES A POTENTIAL RISK TO CONSUMERS DUE TO LACK OF REGULATORY OVERSIGHT. I HAVE REPORTED THIS ISSUE TO GROUPON AND REQUESTED THE PRODUCT'S REMOVAL FROM THEIR MARKETPLACE. I AM SUBMITTING THIS REPORT SO THE FDA IS AWARE OF THE DECEPTIVE MARKETING AND TO HELP PREVENT POTENTIAL HARM TO OTHERS. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041692 FAR IRON STATIC ELECTRICITY-EMITTING DEVICE, COSMETIC USE NZF UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female