FDA Adverse Event
Malfunction
Summary report: N
SCULPTRA
MDR report key: 2973778
·
Received December 28, 2007
Report
- Report Number
- 3002807108-2007-00024
- Event Type
- Malfunction
- Date Received
- December 28, 2007
- Date of Event
- January 1, 2007
- Report Date
- December 5, 2007
- Manufacturer
- GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY/SANOFI-AVENTIS
- Product Code
- LMH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NO INFORMATION
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCULPTRA | WRINKLE FILLER | LMH | GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY/SANOFI-AVENTIS | NA | A7016 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |