FDA Adverse Event Injury Summary report: N

SCULPTRA (POLY L-LACTIC ACID)

MDR report key: 1550607 · Received December 2, 2009

Report

Report Number
3003496686-2009-03312
Event Type
Injury
Date Received
December 2, 2009
Date of Event
November 13, 2009
Report Date
November 16, 2009
Manufacturer
SANOFI-AVENTIS U.S. LLC
Product Code
LMH
PMA / PMN Number
P030050
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
BE
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

INITIAL REPORT: THIS MEDICALLY IMPORTANT CASE REPORT WAS REPORTED ON 16-NOV-09 BY A PHYSICIAN TO OUR LOCAL AFFILIATE. THIS CASE INVOLVES A FEMALE PATIENT (AGE NOS), WHO RECEIVED TWO TREATMENTS WITH POLY-L-LACTIC ACID (SCULPTRA) THERAPY ON UNSPECIFIED DATES. DURING THE SECOND TREATMENT, THE PATIENT RECEIVED 6 ML OF POLY-L- LACTIC ACID (5 ML DISTILLED WATER + 1 CC XYLOCAINE 2% ADRENALIZED). NO ADDITIONAL TREATMENT DETAILS WERE PROVIDED. OTHER SUSPECT DRUGS - IBUPROFEN + PSEUDO-EPHEDRINE (RHINADVIL). RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATION INFORMATION WERE NOT MENTIONED. IN 2009, THE PATIENT EXPERIENCED A QUINCKE'S EDEMA. AS CORRECTIVE TREATMENT, AN ANTIHISTAMINIC (NOS) WAS ADMINISTERED. THE REPORTER STATED THAT THE EVENT WAS IMPROVING THEREAFTER, AND THAT THERE IS NO RELATIONSHIP WITH POLY-L-LACTIC ACID THERAPY. HE ATTRIBUTED THE EVENT TO IBUPROFEN + PSEUDO-EPHEDRINE THERAPY. THE PHYSICIAN DOES NOT WISH TO PROVIDE ADDITIONAL INFORMATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SCULPTRA (POLY L-LACTIC ACID) FACIAL FILLER LMH SANOFI-AVENTIS U.S. LLC UNK

Patients

Seq Age Sex Outcome Treatment
1 Other| R