FDA Adverse Event
Other
Summary report: N
RADIESSE DERMAL FILLER
MDR report key: 2608640
·
Received May 31, 2012
Report
- Report Number
- 2135225-2012-00057
- Event Type
- Other
- Date Received
- May 31, 2012
- Date of Event
- April 1, 2012
- Report Date
- May 31, 2012
- Manufacturer
- MERZ AESTHETICS, INC.
- Product Code
- LMH
- PMA / PMN Number
- P050052
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORDS WERE NOT REVIEWED AS THE LOT NUMBER WAS NOT PROVIDED.
Description of Event or Problem · 1
PT'S ADVERSE EVENTS WERE FORWARDED TO MERZ AESTHETICS, INC. BY (B)(4) AT MERZ (B)(4). DR. (B)(6) INJECTED A FEMALE PT FOR NOSE AUGMENTATION TWO WEEKS AGO AND THE PT CAME BACK A WEEK LATER WITH REDNESS. DR. (B)(6) PRESCRIBED "FLUCLOXACILLIN" FOR 7 DAYS. CURRENTLY, THE PT HAS BEEN ON ANTIBIOTICS FOR 3 DAYS AND THERE IS STILL REDNESS. IN A F/U (B)(4) STATED THAT DR. (B)(6) REPORTED INITIAL REDNESS FOLLOWED BY SWELLING, "FOR THIS REASON HE TREATED WITH ANTIBIOTICS". PT'S RECOVERY STATUS WAS NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RADIESSE DERMAL FILLER | RADIESSE INJECTABLE IMPLANT | LMH | MERZ AESTHETICS, INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |