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U.S. Department of Health and Human Services

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

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GALDERMA LABORATORIES, L. P. SCULPTRA (POLY-L-LACTIC ACID) IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
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).
 
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Brand NameSCULPTRA (POLY-L-LACTIC ACID)
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
GALDERMA LABORATORIES, L. P.
MDR Report Key9197185
MDR Text Key162682168
Report NumberMW5090412
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received10/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 10/15/2019 Patient Sequence Number: 1
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