MAUDE Adverse Event Report: GALDERMA LABORATORIES, L. P. SCULPTRA (POLY-L-LACTIC ACID); IMPLANT, DERMAL, FOR AESTHETIC USE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Autoimmune Reaction (1733); Pain (1994); Scarring (2061); Swelling (2091); Ulcer (2274); Reaction (2414)

Event Date 08/10/2019

Event Type  Injury  

Event Description

Sculptra was injected without taking a pt history or providing informed consent.Severe systemic autoimmune reaction with severe papules, granulomas and modules all over the injection site resulted.Some have migrated beyond the injection site.Face ulcers and cystic acne have resulted.Large doses of prednisone help reduce symptoms but have caused osteoporosis and other terrible side effects.Loss of quality of life.Severe scarring and nerve pain.Needing to resign from job because cannot work due to disease.Sculptra has ruined my face and my life.Fda safety report id# (b)(4).

• Brand Name: SCULPTRA (POLY-L-LACTIC ACID)
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA LABORATORIES, L. P.
• MDR Report Key: 9197185
• MDR Text Key: 162682168
• Report Number: MW5090412
• 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: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 45 YR
• Patient Weight: 52