FDA Adverse Event
Injury
Summary report: N
SCULPTRA
MDR report key: 1932988
·
Received December 15, 2010
Report
- Report Number
- 3003496686-2010-74801
- Event Type
- Injury
- Date Received
- December 15, 2010
- Report Date
- December 15, 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
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INITIAL INFORMATION WAS REC'D FROM A PHYSICIAN VIA A COMPANY SALES REP ON 07-DEC-2010: A PHYSICIAN REPORTED THAT A FEMALE PT (AGE NOT PROVIDED) WAS INJECTED WITH POLY-L-LACTIC ACID (SCULPTRA, LOT# AND EXPIRATION DATE NOT PROVIDED) ON AN UNK DATE. HE STATED THAT WHILE INJECTING POLY-L-LACTIC ACID (SCULPTRA), THE NEEDLE CAME IN CONTACT WITH FACIAL IMPLANT (THAT THE PHYSICIAN WAS UNAWARE OF) AND THE PT DEVELOPED AN INFECTION THAT REQUIRED HOSPITALIZATION. THE OUTCOME OF THE EVENT IS UNK. NO FURTHER RELEVANT INFORMATION WAS PROVIDED.
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 | Hospitalization | CON MEDS - UNK| PREV MEDS - UNK |