FDA Adverse Event
Other
Summary report: N
RESTYLANE INJECTABLE GEL
MDR report key: 2913611
·
Received January 8, 2013
Report
- Report Number
- 2032896-2012-00040
- Event Type
- Other
- Date Received
- January 8, 2013
- Report Date
- December 31, 2012
- Manufacturer
- Q-MED AB
- Product Code
- LMH
- PMA / PMN Number
- P020023/P040
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 10317 | RESTYLANE INJECTABLE GEL | INJECTABLE DERMAL FILLER | LMH | Q-MED AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Other |