MAUDE Adverse Event Report: GALDERMA LABORATORIES, L.P. SCULPTRA; IMPLANT, DERMAL, FOR AESTHETIC USE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Sore Throat (2396); Nodule (4551); Swelling/ Edema (4577)

Event Date 04/01/2021

Event Type  Injury  

Event Description

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.

• Brand Name: SCULPTRA
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA LABORATORIES, L.P.
• MDR Report Key: 13757201
• MDR Text Key: 287249488
• Report Number: MW5108097
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/09/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: BOTOX ; CHOLESTIPOL 4GM DAY
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 50 KG