FDA Adverse Event
Other
Summary report: N
RADIESSE DERMAL FILLER
MDR report key: 2031892
·
Received March 21, 2011
Report
- Report Number
- 2135225-2011-00022
- Event Type
- Other
- Date Received
- March 21, 2011
- Date of Event
- February 16, 2011
- Report Date
- February 21, 2011
- Manufacturer
- MERZ AESTHETICS, INC.
- Product Code
- LMH
- PMA / PMN Number
- P050052
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AT THE TIME OF THE REPORT, THE PT WAS RECOVERING. THE DEVICE HISTORY RECORDS FOR RADIESSE LOT 1023186 WERE REVIEWED; ALL REQUIRED TESTING SPECS WERE MET PRIOR TO RELEASE, THERE WERE NO ABNORMALITIES NOTED.
Description of Event or Problem · 1
THE PT WAS INJECTED IN THE NASOJUGAL FOLDS, EAR AND MARIONETTE LINES ON (B)(6) 2011. ON (B)(6) 2011, 8 DAYS AFTER THE MEDICAL LIFTING WITH RADIESSE, THE PT DEVELOPED A REACTIONAL FACE EDEMA FROM DAY 8 TO DAY 12. AUGMENTIN 1 GRAM, 3 TIMES DAILY BY ORAL ROUTE FOR 7 DAYS AND SOLUPRED 20, 3 TABLETS IN THE MORNING FOR FOUR DAYS WAS PRESCRIBED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RADIESSE DERMAL FILLER | INJECTABLE IMPLANT | LMH | MERZ AESTHETICS, INC. | 1021132 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Other |