FDA Adverse Event
Injury
Summary report: N
SCULPTRA
MDR report key: 1873119
·
Received October 15, 2010
Report
- Report Number
- 3003496686-2010-61263
- Event Type
- Injury
- Date Received
- October 15, 2010
- Date of Event
- January 1, 2010
- Report Date
- October 15, 2010
- Manufacturer
- SANOFIAVENTIS U.S. LLC
- Product Code
- LMH
- PMA / PMN Number
- P030050
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INITIAL INFO WAS RECEIVED FROM A PHYSICIAN VIA A COMPANY REPRESENTATIVE AND RECEIVED BY (B)(6) ON 7-OCT-2010 AND ADDITIONAL INFO WAS REPORTED BY A NURSE: A (B)(6) FEMALE PT RECEIVED TREATMENT WITH POLY-L-LACTIC (SCULPTRA) 1 VIAL ON (B)(6)-2010 FOR AN UNK INDICATION UNDER BOTH OF HER EYES. THE PT RETURNED TO THE PHYSICIAN'S OFFICE IN (B)(6) 2010. SHE DEVELOPED A NODULE ON BOTH HER CHEEKS ON AN UNK DATE IN 2010. THE PHYSICIAN TREATED HER WITH LOW LEVEL LED LIGHTS, "ZANREX", DOXYCYCLINE, AND PREDNISONE. NO MEDICAL HISTORY OR CONCOMITANT MEDICATIONS WERE REPORTED. NO FURTHER RELEVANT INFO WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCULPTRA | FACIAL FILLER | LMH | SANOFIAVENTIS U.S. LLC | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Other | CON MEDS = UNK| PREV MEDS = UNK |