BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMINA FAT IRON

    MDR report key: 14137612 · Received April 15, 2022

    Report

    Report Number
    MW5109122
    Event Type
    Injury
    Date Received
    April 15, 2022
    Date of Event
    April 1, 2022
    Report Date
    April 14, 2022
    Manufacturer
    HEAT IN A CLICK LLC
    Product Code
    NZF
    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

    HAD USED THE DEVICE FOR ABOUT A MONTH. NEVER HAD THE DEVICE EVEN GOT WARM. THIS PARTICULAR MORNING IT WAS SO HOT, THE SECOND IT HIT MY SKIN IT BURNED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1636377 LUMINA FAT IRON STATIC ELECTRICITY-EMITTING DEVICE, COSMETIC USE NZF HEAT IN A CLICK LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female