SCULPTRA *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-03-29 for SCULPTRA * manufactured by Sanofi-aventis Pharmaceuticals.

Event Text Entries

[18148645] I was advised by my physician to use sculptra for injections in the periorbital area of my face to plump up and enhance those areas. Immediately, the sculptra formed a large "pool" under one eye. Since the initial injections, large nodules have formed under both eyes, and they have not dissolved even with steroid injections into the nodules. I have since researched and found out that this is a common occurrence and that sculptra is not safe or effective for the periorbital areas. I have had no satisfaction in correcting the problem, and these side effects were not listed on the consent form, nor on the sanofi-aventis pharmaceutical website.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW1038368
MDR Report Key	697651
Date Received	2006-03-29
Date of Report	2006-03-29
Date of Event	2005-10-20
Date Added to Maude	2006-04-12
Event Key	0
Report Source Code	Voluntary report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	3
Reporter Occupation	PATIENT
Health Professional	3
Initial Report to FDA	0
Report to FDA	0
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	SCULPTRA
Generic Name	POLY-L-LACTIC ACID
Product Code	LMI
Date Received	2006-03-29
Model Number	*
Catalog Number	*
Lot Number	*
ID Number	*
Operator	HEALTH PROFESSIONAL
Device Availability	N
Implant Flag	Y
Date Removed	*
Device Sequence No	1
Device Event Key	686739
Manufacturer	SANOFI-AVENTIS PHARMACEUTICALS
Manufacturer Address	200 CROSSING BLVD PO BOX 6890 BRIDGEWATER NJ 088070890 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention; 2. Deathisabilit	2006-03-29