FDA Adverse Event
Injury
Summary report: N
SCULPTRA
MDR report key: 1873654
·
Received October 13, 2010
Report
- Report Number
- 3003496686-2010-60814
- Event Type
- Injury
- Date Received
- October 13, 2010
- Report Date
- October 12, 2010
- Manufacturer
- SANOFIAVENTIS U.S. LLC
- Product Code
- LMH
- PMA / PMN Number
- PO30050
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INITIAL INFO REPORTED BY A PHYSICIAN TO A SALES REP ON 10/06/2010: A FEMALE CONSUMER RECEIVED TREATMENT WITH INJECTABLE POLY-L-LACTIC ACID (SCULPTRA AESTHETIC) [LOT # AND EXP DATE UNK] AND DEVELOPED A NODULE ON HER JAW LINE. ON (B)(6) 2010, THE PHYSICIAN POPPED IT OUT WITH SURGICAL INTERVENTION AND ADVISED THE SALES REP THAT THERE WAS NO INFECTION AND NO INFLAMMATION; ONLY A NICE COLLAGEN PEARL WHICH HE IS SENDING OFF TO PATHOLOGY. NO FURTHER RELEVANT INFO 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 |