FDA Adverse Event
Injury
Summary report: N
SCULPTRA
MDR report key: 1882341
·
Received October 22, 2010
Report
- Report Number
- 3003496686-2010-63705
- Event Type
- Injury
- Date Received
- October 22, 2010
- Report Date
- October 21, 2010
- Manufacturer
- SANOFI AVENTIS U.S. LLC
- Product Code
- LMH
- PMA / PMN Number
- P030050
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INITIAL INFO RECEIVED FROM A CONSUMER ON 15-OCT-210: A FEMALE RECEIVED TREATMENT WITH POLY-L-LACTIC ACID (SCULPTRA) (LOT # AND EXP DATE UNK) DEVELOPED BUMPS INSIDE HER MOUTH. THE PT DESCRIBED THE BUMPS AS "INSIDE MY MOUTH UP FROM MY TOP LIP". SHE FURTHER REPORTED THAT POLY-L-LACTIC ACID DID NOT GET RID OF THE LINES AROUND HER MOUTH. NO CONCOMITANT MEDICATIONS OR MEDICAL HISTORY WERE REPORTED. NO FURTHER INFO REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCULPTRA | FACIAL FILLER | LMH | SANOFI AVENTIS U.S. LLC | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other | PREV MEDS = UNKNOWN| CON MEDS = UNKNOWN |