FDA Adverse Event
Injury
Summary report: N
RADIESSE DERMAL FILLER
MDR report key: 1486636
·
Received September 24, 2009
Report
- Report Number
- 2135225-2009-00048
- Event Type
- Injury
- Date Received
- September 24, 2009
- Date of Event
- August 14, 2009
- Report Date
- August 31, 2009
- Manufacturer
- BIOFORM MEDICAL, INC.
- Product Code
- LMH
- PMA / PMN Number
- P050052
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PATIENT WAS TREATED WITH KEFLEX AND A MEDROL DOSE PACK AND THE MUCOSAL AREA BEGAN TO HEAL. SOON AFTER, THE OUTER SKIN BELOW THE NOSTRIL BEGAN TO BREAKDOWN WITH CLEAR DRAINAGE AND FURTHER DISCOMFORT. CONSULTING PHYSICIAN, RECOMMENDED USING AN ANTIVIRAL FOR A POSSIBLE HERPETIC ERUPTION. PATIENT WAS ALSO SEEN BY DR. MEDICATIONS; BACTROBAN AND DENAVIR WERE PRESCRIBED. THE PATIENT'S SYMPTOMS ARE RESOLVING. THE DEVICE HISTORY RECORDS FOR LOT #1010881 WERE REVIEWED; THE LOT MET ALL REQUIRED TESTING SPECIFICATIONS AND NO ABNORMALITIES WERE NOTED.
Description of Event or Problem · 1
PHYSICIAN REPORTED A PATIENT INJECTED WITH RADIESSE DERMAL FILLER IN THE NASOLABIAL FOLDS DEVELOPED SEVERE DISCOMFORT AND BREAKDOWN OF THE MUCOSAL AREA OF THE CHEEK, 24 HOURS POST-INJECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RADIESSE DERMAL FILLER | INJECTABLE IMPLANT | LMH | BIOFORM MEDICAL, INC. | 1010881 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |