FDA Adverse Event
Injury
Summary report: N
RADIESSE DERMAL FILLER
MDR report key: 1063451
·
Received June 19, 2008
Report
- Report Number
- 2135225-2008-00039
- Event Type
- Injury
- Date Received
- June 19, 2008
- Date of Event
- March 21, 2008
- Report Date
- June 18, 2008
- Manufacturer
- BIOFORM MEDICAL,
- Product Code
- LMH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
SEVERAL ATTEMPTS WERE MADE TO PROVIDE CONSULTATION TO DR. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE PHYSICIAN REGARDING THIS PATIENT; OUTCOME IS NOT KNOWN. IN CLOSING THIS COMPLAINT, THE MEDICAL DEVICE REPORT DECISION TREES WERE REVIEWED. REVIEW OF THIS EVENT CHANGED THE DECISION SINCE MEDICAL INTERVENTION WAS REQUIRED IN ORDER TO PRECLUDE PERMANENT IMPAIRMENT. WE REGRET THE DELAY IN THE FILING OF THIS REPORT.
Description of Event or Problem · 1
NURSE INJECTOR REPORTED A PATIENT WHO HAD BEEN INJECTED WITH RADIESSE DERMAL FILLER AND HAD EXPERIENCED PAIN, SWELLING, REDNESS ON ONE SIDE. PATIENT WAS EVALUATED BY FAMILY PRACTITIONER WHO DIAGNOSED CELLULITIS. PATIENT WAS PRESCRIBED ANTIBIOTIC AND STEROID.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RADIESSE DERMAL FILLER | INJECTABLE IMPLANT | LMH | BIOFORM MEDICAL, | 1004699 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |