FDA Adverse Event
Injury
Summary report: N
RADIESSE DERMAL FILLER
MDR report key: 1359174
·
Received April 10, 2009
Report
- Report Number
- 2135225-2009-00015
- Event Type
- Injury
- Date Received
- April 10, 2009
- Date of Event
- April 1, 2009
- Report Date
- April 6, 2009
- Manufacturer
- BIOFORM MEDICAL, INC.
- Product Code
- LMH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PT DEVELOPED SWELLING, SORENESS AND A PIMPLE WITH DRAINAGE AT THE INJECTABLE SITE, DETERMINED TO BE CELLULITIS. THE PT WAS TREATED WITH THE ORAL ANTIBIOTIC, AUGMENTIN. ALL SYMPTOMS HAVE RESOLVED. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE REPORTED LOT #1010569, MET ALL SPECIFICATIONS.
Description of Event or Problem · 1
PHYSICIAN REPORTED A PT INJECTED WITH RADIESSE DERMAL FILLER IN THE NLFS DEVELOPED AN INFECTION TWO DAYS AFTER THE INJECTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RADIESSE DERMAL FILLER | INJECTABLE IMPLANT | LMH | BIOFORM MEDICAL, INC. | 1010569 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |