FDA Adverse Event Injury Summary report: N

RHA3

MDR report key: 12108632 · Received July 1, 2021

Report

Report Number
MW5102280
Event Type
Injury
Date Received
July 1, 2021
Date of Event
May 31, 2021
Report Date
June 30, 2021
Manufacturer
REVANCE THERAPEUTICS, INC.
Product Code
LMH
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

ON (B)(6) 2021, I RECEIVED REVANCE RHA3 FILLERS IN MY MARIONETTE LINES. (B)(6) WEEKEND, THOSE FILLERS BECAME HARD, RED AND SWOLLEN. MY FACE IS DEFORMED. I VISITED MY DOCTOR (B)(6) AND HE CONTACTED REVANCE. I WAS PUT ON STEROIDS FOR A WEEK WITH NO CHANGE. ON (B)(6), WHEN I WAS CRYING TO MY SISTER ABOUT HOW I WANTED THIS JUNK OUT OF MY FACE, SHE RECOMMENDED I GET IT DISSOLVED. (SHE IS AN EVENT-PLANNER AND IS NOT IN THE MEDICAL FIELD). I TOLD MY DOCTOR THIS WAS MY PLAN AND HE SAID REVANCE SAID THAT WAS FINE. (WHY WAS THIS NOT RECOMMENDED IN THE FIRST PLACE?) ON (B)(6), I VISITED MY DOCTOR AND HAD MY FIRST ROUND OF HYALURONIDASE. DURING WHICH I CRIED, THEN CRIED IN MY CAR FOR 15 MIN. THE FILLERS MOVED AROUND, STAYED HARD AND SWOLLEN AND RED. THERE WAS SOME REDUCTION BUT SLIGHT. (B)(6), ANOTHER VISIT AND MORE HYALURONIDASE. SMALL IMPROVEMENT. THE AREA IS STILL RED AND SWOLLEN. (B)(6), MORE HYALURONIDASE. TODAY, THE AREA IS STILL RED, HARD AND SWOLLEN. FDA SAFETY REPORT ID # (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1001610 RHA3 IMPLANT, DERMAL, FOR AESTHETIC USE LMH REVANCE THERAPEUTICS, INC.

Patients

Seq Age Sex Outcome Treatment
1 53 YR Other