FDA Adverse Event
Other
Summary report: N
RADIANCE FN
MDR report key: 495799
·
Received November 12, 2003
Report
- Report Number
- 2135225-2003-00005
- Event Type
- Other
- Date Received
- November 12, 2003
- Report Date
- November 11, 2003
- Manufacturer
- BIOFORM, INC.
- Product Code
- LMH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
PATIENT REPORTS NUMBNESS FROM BENEATH PAROTID GLAND TO BENEATH CHIN, BOTH SIDES OF FACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RADIANCE FN | INJECTABLE IMPLANT | LMH | BIOFORM, INC. | 8027-3 | C1202124 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |