FDA Adverse Event
Injury
Summary report: N
SCULPTRA (POLY-L-LACTIC ACID)
MDR report key: 1873608
·
Received October 12, 2010
Report
- Report Number
- 3003496686-2010-60552
- Event Type
- Injury
- Date Received
- October 12, 2010
- Report Date
- October 4, 2010
- Manufacturer
- SANOFIAVENTIS U.S. LLC
- Product Code
- LMH
- PMA / PMN Number
- PO30050
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INITIAL REPORT: THIS MEDICALLY IMPORTANT SPONTANEOUS CASE FROM (6)(6) WAS REPORTED BY CONSUMER (FROM A PHYSICIAN'S OFFICE) ON (6)(6) 2010 ((6)(6)). THE REPORTER STATES THAT THIS PHYSICIAN MAINTAINS A BLOG ONLINE FOR BOTH UNITED STATES AND INTERNATIONAL PATIENTS AND LEARNED OF A FEMALE PATIENT IN (6)(6) REPORTING "LUMPS AND BUMPS" ON HER FACE AFTER BEING TREATED WITH POLY-L-LACTIC ACID. NO ADDITIONAL TREATMENT DETAILS WERE PROVIDED. RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATION INFORMATION WERE NOT MENTIONED. ACTION TAKEN/CORRECTIVE TREATMENT/OUTCOME - UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCULPTRA (POLY-L-LACTIC ACID) | FACIAL FILLER | LMH | SANOFIAVENTIS U.S. LLC | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | CON MEDS = UNKNOWN| PREV MEDS = UNKNOWN |