MAUDE Adverse Event Report: HEAT IN A CLICK LLC. FAT IRON LUMINA NRG; STATIC ELECTRICITY-EMITTING DEVICE, COSMETIC USE

Model Number FAT IRON

Device Problem Unintended Electrical Shock (4018)

Patient Problem Burn(s) (1757)

Event Date 01/05/2021

Event Type  Injury  

Event Description

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).

Event Description

Additional infromation received for report mw5107140 on 03/10/2022 for procode.Procode: nzf.

• Brand Name: FAT IRON LUMINA NRG
• Type of Device: STATIC ELECTRICITY-EMITTING DEVICE, COSMETIC USE
• Manufacturer (Section D): HEAT IN A CLICK LLC.
• MDR Report Key: 13425219
• MDR Text Key: 285036314
• Report Number: MW5107140
• Device Sequence Number: 1
• Product Code: ISA
• 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,Followup
• Report Date: 01/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FAT IRON
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White