FDA Adverse Event Injury Summary report: N

SCULPTRA (POLY-L-LACTIC ACID)

MDR report key: 2851218 · Received November 27, 2012

Report

Report Number: 3002807108-2012-85989
Event Type: Injury
Date Received: November 27, 2012
Date of Event: September 1, 2012
Report Date: November 27, 2012
Manufacturer: AVENTIS PHARMA GRUPPO LEPETIT S.R.L.
Product Code: LMH
PMA / PMN Number: P030050
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NO
Reporter Occupation: PHYSICIAN

Narratives

Description of Event or Problem · 1

INITIAL INFO FOR THIS SERIOUS UNSOLICITED REPORT ((B)(4)) WAS REPORTED BY A PHYSICIAN ON (B)(6) 2012. THIS CASE INVOLVES A (B)(6) FEMALE PT WHO RECEIVED TREATMENT WITH POLY-L-LACTIC ACID (SCULPTRA) WITH SECOND TIME IN (B)(6) 2011 FOR SKIN DEPRESSION CORRECTION. ONE YEAR FROM THE SECOND POLY-L-LACTIC ACID INJECTION (IN (B)(6) 2012), THE PT EXPERIENCED NODULES. IT WAS REPORTED THAT THE PT RECEIVED INJECTIONS IN THE LYMPH AS WELL (SMALL SORE NODES, TO BE CONFIRMED). THE PT WAS TREATED WITH CEFALEXIN MONOHYDRATE (KEFLEX) AND THE LYMPH NODES WERE LESS SORE. THE PT STILL HAS NODULES ON FACE. NO MEDICAL HISTORY OR CONCOMITANT MEDICATIONS WERE PROVIDED. CORRECTIVE TREATMENT: CEFALEXIN MONOHYDRATE. ACTION TAKEN: NOT APPLICABLE. OUTCOME: NOT RECOVERED. (B)(4). PHARMACOVIGILANCE COMMENT: NODULES ARE CONSIDERED A COMMON AND LISTED EVENT FOR POLY-L-LACTIC ACID. MOST EVENTS OF THIS NATURE RESOLVED SPONTANEOUSLY OVER TIME. THESE EVENTS ARE TYPICALLY A COSMETIC CONCERN AND NOT A MAJOR MEDICAL ISSUE THAT WOULD RESULT IN PERMANENT DISABILITY, A LIFE-THREATENING CONDITION, OR FATAL INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SCULPTRA (POLY-L-LACTIC ACID)	FACIAL FILLER	LMH	AVENTIS PHARMA GRUPPO LEPETIT S.R.L.		UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR		Other\| R	CON MEDS = UNK\| PREV MEDS = UNK