BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAT IRON GEL PRIMER

    MDR report key: 17586354 · Received August 18, 2023

    Report

    Report Number
    MW5144798
    Event Type
    Malfunction
    Date Received
    August 18, 2023
    Date of Event
    August 12, 2023
    Report Date
    August 15, 2023
    Manufacturer
    UNKNOWN
    Product Code
    GYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    LUMINA HTTPS://LUMINANRG.COM/PRODUCTS/FAT-IRON-GEL-PRIMER IS SELLING A CONDUCTIVE GEL (REGULATED BY 21 CFR 882.1275). IT HAS NO LIST OF INGREDIENTS ON IT. IT HAS NO WARNINGS OR CAUTION STATEMENTS AS REQUIRED OF OTHER ELECTROCONDUCTIVE GELS. THEIR GEL HAS NEVER HAD AN FDA-COMPLIANT LABEL. I ASKED WHERE IT IS, AND WAS TOLD "THE GEL IS FDA APPROVED." THIS MEANS THEY MUST HAVE SUBMITTED 510(K) PREMARKET DISCLOSURES FOR THE GEL, RIGHT? IF YES, WHERE IS THE LABEL? IT'S NOT ON THE BOTTLE. IT'S NOT ON THE WEBSITE. I DID NOT BUY THEIR GEL. HOWEVER, THE GEL ORIGINALLY DISTRIBUTED WITH THEIR ELECTROCONDUCTIVE MEDICAL DEVICE (WHICH I PURCHASED VIA THEIR KICKSTART CAMPAIGN A FEW YEARS AGO) ALSO LACKS A LABEL. I STILL HAVE THAT ORIGINAL PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035158 FAT IRON GEL PRIMER MEDIA, ELECTROCONDUCTIVE GYB UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown