FDA Adverse Event Injury Summary report: N

RESTYLANE SILK

MDR report key: 8491735 · Received April 5, 2019

Report

Report Number
MW5085635
Event Type
Injury
Date Received
April 5, 2019
Date of Event
January 18, 2019
Report Date
April 3, 2019
Manufacturer
GALDERMA LABORATORIES, L.P.
Product Code
LMH
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
GA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I GOT FILLERS (RESTYLANE SILK, LYFT) DONE ON (B)(6). TWO WEEKS AFTER MY FACE STARTED TO SWELL. AND WAS CONSTANT UNTIL I DECIDED TO GO BACK TO THE NP WHO DID IT. SHE WAS OUT OF TOWN AND I HAD TO WAIT 1 WEEK TO SEE HER. THEN, WHEN I DID, SHE TOLD ME TO TAKE ANTIHISTAMINE AND ANTI INFLAMMATORY FOR ONE MONTH STRAIGHT EVERY DAY. THE NEXT DAY IT BECAME WORSE AND I WENT TO MY PRIMARY WHO PRESCRIBED ME ANTIBIOTICS. THEN I WENT TO THE NP AGAIN AND WAS PUT ON STEROIDS FOR 7 DAYS, THE SWELLING WENT DOWN, BUT AS I GOT OFF THE STEROIDS, IT STARTED AGAIN. I WENT TO ANOTHER DERMATOLOGIST WHO TOLD ME: EITHER THE PRODUCT WAS TAMPERED WITH; RESTYLANE LYFT SHOULD NEVER BE USED WHERE IT WAS USED; THE AREA WAS NOT CLEANED PROPERLY THEREFORE BACTERIAL FROM THE SKIN WAS INJECTED IN. THE NP DID NOT WANT TO DISSOLVE THE PROBLEM SAYING THAT IF SHE DID, SHE MIGHT DISSOLVE MY OWN HYALURONIC ACID. TWO DAYS LATER, I CALLED HER AND SAID I WANTED IT DISSOLVED FOR I DID NOT WANT TO GO THROUGH THIS ANYMORE. IT'S BEEN A WEEK NOW, AND IT STARTED SWELLING UP AGAIN, NOW IT FEELS LIKE THE BONES IN MY FACE ARE SORE. SHE DID NOT DISSOLVE ALL OF IT. MY MOM ALSO HAS INJECTIONS DONE WITH THE SAME PERSON; HOWEVER, WITH A DIFFERENT PRODUCT [JUVEDERM VOLVEMOS]. AND AFTER TWO WEEKS, SHE IS HAVING THE SAME REACTION. I HAVE USED JUVEDERM BEFORE AND NEVER HAD A PROBLEM. BUT I FIND A COINCIDENCE, INJECTIONS WERE DONE AT THE SAME PRACTICE. THE (B)(6), BY THE SAME PERSON (B)(6). WITH DIFFERENT BRANDS OF HYALURONIC ACID, SAME REACTION; ALMOST OBSTRUCTION VISION. FDA SAFETY REPORT ID# (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
282770 RESTYLANE SILK IMPLANT DERMAL FOR AESTHETIC USE LMH GALDERMA LABORATORIES, L.P.
282771 RESTYLANE LYFT IMPLANT DERMAL FOR AESTHETIC USE LMH GALDERMA LABORATORIES, L.P.
282772 JUVEDERM IMPLANT DERMAL FOR AESTHETIC USE LMH ALLERGAN

Patients

Seq Age Sex Outcome Treatment
1 26 YR Hospitalization| O| R