Description of Event or Problem · 1
INITIAL INFORMATION REPORTED BY A PHYSICIAN TO A SALES REP ON (B)(6) 2010 AND ADDITIONAL INFORMATION REC'D FROM A NURSE ON (B)(6) 2010: A (B)(6) FEMALE REC'D TREATMENT WITH INJECTABLE POLY-L-LACTIC ACID (SCULPTRA AESTHETIC) [LOT # AND EXPIRATION DATE UNK] 1 ML IN HER RIGHT TEMPLE ON (B)(6) 2010 FOR COSMETIC PURPOSES. THE INJECTABLE POLY-L-LACTIC ACID WAS RECONSTITUTED ABOUT 12 HOURS BEFORE THE PT REC'D TREATMENT WITH SALINE. ON (B)(6) 2010, SHE CONTACTED THE PHYSICIAN AND REPORTED THAT SHE DEVELOPED A LUMP IN THE AREA ON HER TEMPLE THAT WAS RAISED ABOUT 1 INCH, RED IN COLOR AND VERY HARD. SHE WAS DIRECTED TO MASSAGE THE AREA. ON (B)(6) 2010, SHE WENT TO THE PHYSICIAN'S OFFICE WHERE AN ATTEMPT WAS MADE TO TRY AND BREAK UP THE VISIBLE LUMP WITH A NEEDLE AND 0.15 SALINE (UNITS UNSPECIFIED). THE PHYSICIAN SAID THAT IT WAS TOO SOON TO BE COLLAGEN AND REITERATED THAT THE AREA WAS SO RED AND SO HARD. ON (B)(6) 2010, SHE RETURNED TO THE OFFICE FOR A FOLLOW UP AND THE AREA LOOKED TO BE IMPROVING. HER FITZPATRICK SKIN TYPE WAS REPORTED AS FAIR AND CAUCASIAN. MEDICAL HISTORY REPORTED AS NO IMMUNOLOGICAL OR COLLAGE-VASCULAR DISEASE, OCCASIONAL HIVES AS A CHILD AND ROSACEA. CONCOMITANT MEDICATIONS INCLUDED METRONIDAZOLE (METROCREAM) FOR ROSACEA. NO FURTHER RELEVANT INFORMATION REPORTED.