BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FAT IRON LUMINA NRG

    MDR report key: 13425219 · Received February 1, 2022

    Report

    Report Number
    MW5107140
    Event Type
    Injury
    Date Received
    February 1, 2022
    Date of Event
    January 5, 2021
    Report Date
    January 29, 2022
    Manufacturer
    HEAT IN A CLICK LLC.
    Product Code
    ISA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    LUMINA NRG FAT IRON, SHOCKED AND BURNED ME, THEY ADVERTISE AS FDA APPROVED, THEY REFUSE TO REFUND MY MONEY, THE ITEM AND COMPANY ARE A SCAM. FDA SAFETY REPORT ID# (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFROMATION RECEIVED FOR REPORT MW5107140 ON 03/10/2022 FOR PROCODE. PROCODE: NZF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550966 FAT IRON LUMINA NRG STATIC ELECTRICITY-EMITTING DEVICE, COSMETIC USE ISA HEAT IN A CLICK LLC. FAT IRON

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Other