FDA Adverse Event
Other
Summary report: N
RADIESSE DERMAL FILLER
MDR report key: 2020348
·
Received March 11, 2011
Report
- Report Number
- 2135225-2011-00017
- Event Type
- Other
- Date Received
- March 11, 2011
- Date of Event
- December 1, 2010
- Report Date
- February 14, 2011
- Manufacturer
- MERZ AESTHETICS, INC.
- Product Code
- LMH
- PMA / PMN Number
- P050052
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE PT WHO REPORTED THE EVENT HAS NOT RESPONDED TO FURTHER CONTACT.
Description of Event or Problem · 1
THE PT WAS INJECTED WITH RADIESSE IN MID (B)(6). THE PT STATED THAT THE BRUISES WERE GONE TWO WEEKS AFTER INJECTION. THE PT HAS BRIGHT PINK SPOTS IN THE TREATED AREAS (UNDER EYES - DARK CIRCLES AREA). AFTER TWO MONTHS, THE PINK SPOTS DON'T SEEM TO FADE AWAY. THE PT STATED THAT SHE WAS PRESCRIBED BIAFINE AND ANTIBIOTICS (ANTIBIOTIC NAME, DATE PRESCRIBED, DOSE AND DURATION NOT PROVIDED). THE PT STATED THAT SHE HAD NO RESULTS FROM THE PRESCRIPTIONS.
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 |