FDA Adverse Event
Injury
Summary report: N
RADIESSE DERMAL FILLER
MDR report key: 1202818
·
Received October 16, 2008
Report
- Report Number
- 2135225-2008-00062
- Event Type
- Injury
- Date Received
- October 16, 2008
- Date of Event
- October 2, 2008
- Report Date
- October 16, 2008
- Manufacturer
- BIOFORM MEDICAL
- Product Code
- LMH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DURING A FOLLOW-UP WITH THE PT, THE SYMPTOMS ARE ABOUT 70% HEALED, WITH ONLY SOME RESIDUAL REDNESS REMAINING. THE RADIESSE INJECTING PHYSICIAN'S IDENTITY WAS NOT REVEALED; THEREFORE, NO FOLLOW-UP COULD BE CONDUCTED WITH A MEDICAL PROFESSIONAL.
Description of Event or Problem · 1
PATIENT WAS INJECTED WITH RADIESSE DERMAL FILLER IN THE CHIN AND IN THE TIP AND BRIDGE OF THE NOSE; WITHIN THE FIRST 3-4 HOURS POST INJECTION, THE PT DEVELOPED AN INFECTION, REDNESS AND SWELLING. THE PT WAS PRESCRIBED KEFLEX FOR THE INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RADIESSE DERMAL FILLER | INJECTABLE IMPLANT | LMH | BIOFORM MEDICAL | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |