Description of Event or Problem · 1
INITIAL INFORMATION RECEIVED FROM A CONSUMER'S HUSBAND, WHO IS ALSO A HEALTHCARE PROFESSIONAL, ON (B)(6) 2011: A (B)(6) FEMALE INITIATED TREATMENT WITH INJECTABLE POLY-L-LACTIC ACID (SCULPTRA) [LOT # AND EXPIRATION DATE UNKNOWN] AT AN UNKNOWN DOSE FOR THE INDICATION "TO LOOK GOOD" IN (B)(6) 2009. SHE WAS NOT SURE HOW MANY TREATMENTS SHE RECEIVED. IN (B)(6) 2009, SHE RECEIVED POLY-L-LACTIC ACID UNDER HER LOWER EYELIDS. WITHIN A WEEK OR SO, SHE GOT LUMPS UNDER BOTH OF HER EYES THAT ARE "PEA-SIZE". ONE SIDE HAS A SMALL LUMP LIKE A SMALL "BEEBEE" UNDER THE SKIN SURFACE AND THE OTHER SIDE LOOKS LIKE THE MATERIAL LAID OUT FLATTER. THERE ARE 2 VISIBLE LUMPS AND IN BETWEEN THEM THERE IS A DEPRESSION; IT IS NOT EVENLY DISTRIBUTED. THERE IS NO ACTIVE INFLAMMATION, BUT THE AREA LOOKS DISCOLORED SOMETIMES. SHE HAS BEEN TO THE DOCTOR SEVERAL TIMES WITHIN THE LAST 2 YEARS FOR CORRECTION AND "SEVERAL THINGS" WERE DONE INCLUDING SALINE INJECTION. THE DOCTOR SUGGESTED OPERATING ON HER EYELID, BUT THAT MAY LEAVE A SCAR. A BIOPSY HAS NOT BEEN PERFORMED. THERE WAS NO EVIDENCE OF A SYSTEMIC PROCESS. THERE WAS NO EVIDENCE OF PERMANENT IMPAIRMENT OF A BODY FUNCTION OR BODY STRUCTURE. IT WAS UNKNOWN IF THE ADVERSE EVENT WAS EXPECTED TO BE IRREVERSIBLE. THE EVENTS REMAINED ONGOING AT THE TIME OF THIS REPORT. MEDICAL HISTORY INCLUDED HAVING PREVIOUS FILLERS FOR FINE LINES WITH NO PROBLEM. THE CONSUMER HAD NO HISTORY OF IMMUNOLOGICAL OR COLLAGEN-VASCULAR DISEASE. NO FURTHER RELEVANT INFORMATION REPORTED.