FDA Adverse Event
Other
Summary report: N
RADIESSE DERMAL FILLER
MDR report key: 1420435
·
Received May 19, 2009
Report
- Report Number
- 2135225-2009-00023
- Event Type
- Other
- Date Received
- May 19, 2009
- Date of Event
- April 30, 2009
- Report Date
- May 4, 2009
- Manufacturer
- BIOFORM MEDICAL, INC.
- Product Code
- LMH
- PMA / PMN Number
- P050052
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DURING A FOLLOW-UP WITH THE CLINIC, IT WAS REPORTED THAT THE PATIENT'S SYMPTOMS HAD RESOLVED. THE DEVICE HISTORY RECORDS FOR RADIESSE LOT 1013296 WERE REVIEWED; THE TESTING SPECIFICATIONS HAD BEEN MET.
Description of Event or Problem · 1
A PT WHO HAD BEEN INJECTED WITH RADIESSE DERMAL FILLER IN THE NASO LABIAL FOLDS AND MARIONETTE LINES ON (B) (6) 2009, DEVELOPED SEVERE PAIN, TENDERNESS, BLEEDING AND A CRUSTING NEAR THE NARES, WHICH LED TO INFECTION. THE PT WAS PRESCRIBED KEFLEX (ANTIBIOTIC) AND AFTER 12 HOURS THE SYMPTOMS HAD IMPROVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RADIESSE DERMAL FILLER | INJECTABLE IMPLANT | LMH | BIOFORM MEDICAL, INC. | 1013296 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |