FDA Adverse Event Injury Summary report: N

SCULPTRA

MDR report key: 13757201 · Received March 11, 2022

Report

Report Number
MW5108097
Event Type
Injury
Date Received
March 11, 2022
Date of Event
April 1, 2021
Report Date
March 9, 2022
Manufacturer
GALDERMA LABORATORIES, L.P.
Product Code
LMH
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

ON (B)(6) 2021 I VISITED (B)(6). I RECEIVED SCULPTRA-2 VIALS, 2-RESTYLANE LYFT, 50U-BOTOX,1-RESTYLANE KYSSE BY INJECTOR (B)(6). THE NEXT DAY, (B)(6) 2021, I FOUND A MARBLE SIZE NODULE BEHIND THE LEFT EAR. I CALLED (B)(6), SPOKE WITH (B)(6) INJECTOR, SHE SAID IT WAS NORMAL AND TO MASSAGE. ON (B)(6) 2021 SEVERAL MORE NODULES ON SCALP, BACK OF THE HEAD, AND NECK ALL ON THE LEFT SIDE, WERE VERY PAINFUL. I MASSAGED AS I WAS TOLD FOR WITH THE FIRST NODULE. ON (B)(6) 2021 I CALLED (B)(6), I EXPLAINED ABOUT ALL THE NODULES, WAS SEEN APPROX 30 MIN LATER. (B)(6) -INJECTOR EXAMINED ((B)(6) ALSO LOOKED AND FELT NODULES) SAID I COULD GO AND SEE MY DOCTOR OR GO TO URGENT CARE OR COULD WAIT. I DECIDED TO WAIT SINCE NODULES WERE SMALLER. ON (B)(6) 2021 I WOKE UP WITH A SORE THROAT ON MY LEFT SIDE. I WENT TO URGENT CARE AND EXPLAINED THE SITUATION TO PA ABOUT THE FILLERS AND NODULES, ALL BEING ON THE LEFT SIDE. SHE ALSO CHECKED FOR STREP. STREP NEGATIVE. PA MENTIONED MOST LIKELY AN ADVERSE SIDE EFFECT TO FILLERS. I HAVE ALSO FELT PAIN AND SWELLING IN BOTH OF MY ARMS, ESPECIALLY MY LEFT ARM. THIS TOOK SEVERAL WEEKS TO CLEAR UP FOR THE MOST PART. TO THIS DAY AT TIMES, I STILL FEEL SOME IRRITATION AND CONTINUE TO HAVE NODULES ALONG THE LEFT SIDE OF MY NECK. SOME DAYS THE NODULES FEEL LARGER THAN OTHER DAYS. I ALSO NOW HAVE ELEVATED ALT SHOWING ON MY BLOODWORK. NEVER HAD THIS ISSUE PRIOR TO SCULPTRA AS I HAVE HAD BOTOX AND RESTYLANE LYFT WITH NO PROBLEMS. COSMETIC-LOSS OF FACIAL VOLUME.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
30259 SCULPTRA IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA LABORATORIES, L.P.
30260 RESTYLANE LYFT IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA / Q-MED AB

Patients

Seq Age Sex Outcome Treatment
1 50 YR Female Other BOTOX | CHOLESTIPOL 4GM DAY