FDA Adverse Event
Injury
Summary report: N
SCULPTRA
MDR report key: 1851171
·
Received September 30, 2010
Report
- Report Number
- 3003496686-2010-57418
- Event Type
- Injury
- Date Received
- September 30, 2010
- Report Date
- September 30, 2010
- Manufacturer
- SANOFIAVENTIS U.S. LLC
- Product Code
- LMH
- PMA / PMN Number
- P030050
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INITIAL INFORMATION RECEIVED FROM A CONSUMER ON (B)(6) 2010: A MALE PATIENT WHO RECEIVED TREATMENT WITH POLY-L-LACTIC ACID (SCULPTRA AESTHETIC, LOT# AND EXP DATE UNKNOWN), EXPERIENCED A LUMP UNDER HIS LEFT EYE. HE STATED HE RECEIVED HIS LAST TREATMENT IN (B)(6) 2009 AND NOW HAS KNOTS IN HIS FACE. HE WAS INJECTED UNDER HIS EYES AND IN HIS CHIN. HE STATED HE SPOKE WITH HIS PHYSICIAN WHO STATED THAT HE COULD PUT SOME MORE PRODUCT AROUND IT TO COVER IT. HE STATED HE NOW HAS LUMPS UNDER BOTH EYES. NO CONCOMITANT MEDICATIONS OR MEDICAL HISTORY REPORTED. NO FURTHER INFORMATION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCULPTRA | FACIAL FILLER | LMH | SANOFIAVENTIS U.S. LLC | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | PREV MEDS UNK| CON MEDS = UNK |