FDA Adverse Event
Other
Summary report: N
RADIESSE DERMAL FILLER
MDR report key: 2995256
·
Received February 28, 2013
Report
- Report Number
- 2135225-2013-00017
- Event Type
- Other
- Date Received
- February 28, 2013
- Date of Event
- January 8, 2013
- Report Date
- February 1, 2013
- Manufacturer
- MERZ AESTHETICS, INC.
- Product Code
- LMH
- PMA / PMN Number
- P050052
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE PT PROVIDED HER E-MAIL ADDRESS. MERZ AESTHETICS, INC. SENT E-MAIL ON (B)(4) 2013, TO THE PT REQUESTING ADD'L INFO. TO DATE, NO FURTHER INFO WAS REC'D.
Description of Event or Problem · 1
MERZ AESTHETICS, INC. RECEIVED A REPORT FROM THE (B)(6), WHICH WAS REC'D THROUGH (B)(4)MEDWATCH PROGRAM. A PT REPORTED THAT RADIESSE FILLER ADMINISTERED BY MD. THE PT DEVELOPED RED RAISED RASH ON ONE CHEEK, EXTREME SWELLING. THREE DAYS POST INJECTION REQUIRING TAPER PACK OF STEROIDS AND ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 86681 | RADIESSE DERMAL FILLER | RADIESSE INJECTABLE IMPLANT | LMH | MERZ AESTHETICS, INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |