MAUDE Adverse Event Report: UNKNOWN FAT IRON GEL PRIMER; MEDIA, ELECTROCONDUCTIVE

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2023

Event Type  malfunction  

Event Description

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.

• Brand Name: FAT IRON GEL PRIMER
• Type of Device: MEDIA, ELECTROCONDUCTIVE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17586354
• MDR Text Key: 321724219
• Report Number: MW5144798
• Device Sequence Number: 1
• Product Code: GYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1