FDA Adverse Event
Other
Summary report: N
RADIESSE DERMAL FILLER
MDR report key: 3011205
·
Received March 15, 2013
Report
- Report Number
- 2135225-2013-00026
- Event Type
- Other
- Date Received
- March 15, 2013
- Report Date
- February 15, 2013
- Manufacturer
- BIOFORM MEDICAL, INC.
- Product Code
- LMH
- PMA / PMN Number
- P050052
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORDS FOR RADIESSE WERE NOT REVIEWED AS THE LOT NUMBER WAS UNK.
Description of Event or Problem · 1
THIS COMPLAINT WAS FORWARDED BY MERZ PHARMACEUTICALS GMBH, GERMANY. THE PHYSICIAN INJECTED RADIESSE TO A PT AND 15 DAYS LATER THE PT WAS TREATED AGAIN, BUT 2 DAYS LATER THE PT PRESENTED THE TREATED AREA WITH INFLAMMATION AND INDURATION. THE PHYSICIAN THINKS THAT THE REACTION PROBABLY IS CAUSED BY AN INFECTION. THE PT IS BEING TREATED WITH ANTIBIOTICS AND CORTICOSTEROIDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 110115 | RADIESSE DERMAL FILLER | RADIESSE INJECTABLE IMPLANT | LMH | BIOFORM MEDICAL, INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |