• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

Lot Number A7020
Event Date 12/20/2007
Event Type  Injury  
Event Description

Manufacturer Narrative

A female received sculptra into hands to treat very thin hands. Had 3/4 sessions. States massaged hands 4 xs daily for 1 week after injections. Experienced areas of clumping and a mass of balls in each hand. In one hand the clumping was not even near where she was injected. Reports the areas stick up and are very noticeable. States her hands looked better before the sculptra. Was told by her physician that it might take 2 years to go away. Additional info ptc investigation results show that this kind of event is not batch related. No faults, defects, damages detectable. Conclusion: no faults detectable. The consumer confirmed experienced pea size lumps, clumped together on her hands and that the event is ongoing. Indicates the sculptra injections were given to her by a nurse and that no biopsy was taken. Additional info from legal 01oct09: in 2007, consumer rec'd 1 bottle of sculptra on both hands. Five months later, she received a half bottle (3 cc) of sculptra. In 2008, received botox and a half bottle of sculptra. One-quarter of the bottle of sculptra was injected into her right hand. Received a half bottle of sculptra six months later. She rec'd 1cc of sculptra in the thumb, index and right. In 2009, the pt saw her physician and expressed concern regarding some bumps in her bilateral hands from sculptra injections. Two months later, pt came to office for botulinum toxin type a treatment, and it was noted that the bumps were enlarged. Additional info from consumer via legal on 13oct09: she reported that the sculptra had moved into a big ball at the top of her hand with a lot of lumps in it. Sculptra was never injected there but she stated that it looked like a big knot on the top of her hand. The other hand had lumps that were just in one area and separated. Her right hand had a big ball with a few lumps that have shifted and were very noticeable. It did not seem to be getting bigger as it had been over a year. She also stated that she did not see any change. Additional lot #s: a7017, exp date: 06/30/2009. Explanted in 2008, lot# a5010, exp date: 11/30/2007, explanted in 2007.

Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceINJECTABLE
Manufacturer (Section D)
200 crossing blvd.
po box 6890
bridgewater NJ 08807 089
Manufacturer (Section G)
localita valcanello
Manufacturer Contact
200 crossing blvd.
po box 6890
bridgewater , NJ 08807-0890
MDR Report Key1514815
Report Number3002807108-2009-00087
Device Sequence Number1
Product CodeLMH
Report Source Manufacturer
Source Type Consumer
Reporter Occupation NO INFORMATION
Type of Report Initial
Report Date 04/24/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/21/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date07/31/2009
Device LOT NumberA7020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/13/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Type of Device Usage Initial