MAUDE Adverse Event Report: UNKNOWN NEATCELL PEN; POWERED LASER SURGICAL INSTRUMENT

Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	08/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
There is a company doing fraud by claiming to have the only fda approved laser for home use and at home tattoo removal.They have a fake fda certificate.The laser they have isn't regulated and most certainly isn't approved for home use and by lay persons.I got burned by the device and it also doesn't work.They have mention of the fda all over their website with these dangerous products as if you have endorsed them and their fraud.This device burns the skin and doesn't work as described and has fraudulent intended use.

• Brand Name: NEATCELL PEN
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 20127705
• Report Number: MW5159180
• Device Sequence Number: 17963614
• Product Code: GEX
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 08/28/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/28/2024
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/30/2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American