FDA Adverse Event Injury Summary report: N

REJUVAPEN NXT

MDR report key: 22461366 · Received July 9, 2025

Report

Report Number
MW5172478
Event Type
Injury
Date Received
July 9, 2025
Date of Event
June 13, 2025
Report Date
June 14, 2025
Manufacturer
REFINE USA, LLC
Product Code
QAI
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I HAD A MICRO-NEEDLING PROCEDURE THAT CAUSED HOLES AND INJURY TO MY FACE AND SKIN. I AM VERY CONCERNED THAT I WILL HAVE SCARRING. I AM EXTREMELY SWOLLEN AND BRUISED AND I AM TRAUMATIZED BY THE EXPERIENCE. MY FACE AND SKIN WILL NOT BE THE SAME AND I SHOULD HAVE NOT HAD MICRO-NEEDLING WITH THIS MEDICINE. I FOLLOWED THE POST CARE INSTRUCTIONS BUT MY SKIN STILL VERY RED WITH BUMPS, BRUISING AND BURNS. MY FACE HURTS IF I TOUCH IT. THEY SAID THIS WOULD CLEAR MY WRINKLES AND FINE LINES AND HELP MY SKIN HAVE MORE COLLAGEN, BUT IT DID THE EXACT OPPOSITE AND IT SCARRED ME FOR LIFE. THEY ADVERTISE ALL THESE FALSE LIES WILL HELP GET RID OF WRINKLES AND YOUR SKIN WILL HAVE MORE COLLAGEN AND BE PLUMP. ALL LIES. THIS SHOULD NOT HAVE HAPPENED AND DO NOT WANT THIS TO HAPPEN TO ANYONE ELSE. UNLESS THEY ARE A DOCTOR OR SURGEON, THEY SHOULD NOT BE ALLOWED TO CAUSE THIS TYPE OF INJURY. ALL THEY CARE ABOUT IS PROFIT AND THE FDA SHOULD NOT ALLOW THIS MORE PATIENTS ARE GOING TO BE HARMED BY WHAT THEY ARE DOING. I ASKED THEM WHERE THEIR MACHINE AND NEEDLES ARE MADE, AND I WAS TOLD USA. AND I ASKED THEM IF THE MACHINE AND NEEDLES WERE REVIEWED BY FDA, AND THEY SAID YES. PLEASE LOOK INTO THIS. IS THE REJUVAPEN MACHINE AND NEEDLES APPROVED BY FDA TO USE. THIS SHOULD NOT HAVE HAPPENED, AND I DON'T NOT WANT IT TO HAPPEN TO ANYONE ELSE. I WISH TO STAY ANONYMOUS AS I DO NOT WANT ANY PROBLEMS WITH THE COMPANY. THEY ASKED ME NOT TO SPEAK ABOUT THIS AND OFFERED ME FREE PRODUCT, BUT I FEEL IT IS IMPORTANT TO SPEAK UP SO THERE IS NOT MORE HARM CAUSED TO ANYONE ELSE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
996895 REJUVAPEN NXT POWERED MICRONEEDLE DEVICE QAI REFINE USA, LLC

Patients

Seq Age Sex Outcome Treatment
1 NA Female Other