Description of Event or Problem · 1
INITIAL REPORT: THIS SERIOUS UNSOLICITED DEVICE CASE FROM UNITED STATES WAS INITIALLY RECEIVED BY LICENSE PARTNER (B)(4) ON (B)(6) 2012 FROM A PHYSICIAN VIA SALES REPRESENTATIVE AND WAS FORWARDED TO SANOFI ON (B)(4) 2012 AS CASE ID (B)(4). THE INFORMATION RECEIVED BY LICENSEE FOR THE DATES (B)(6) 2012 FROM A NURSING PRACTITIONER WAS FORWARDED IN A SINGLE REPORT TO SANOFI WITH THE CSD OF (B)(4) 2012. BASED ON INFORMATION RECEIVED ON (B)(6) 2012, THIS CASE WAS UPGRADED FROM NON-SERIOUS TO SERIOUS. THE BELOW NARRATIVE INCLUDED AN INITIAL REPORT RECEIVED FROM A PHYSICIAN VIA A SALES REPRESENTATIVE ON (B)(6) 2012 PLUS SUBSEQUENT FOLLOW-UP: A (B)(6) FEMALE PATIENT INITIATED POLY-L-LACTIC ACID (SCULPTRA) (LOT: A1043 AND EXPIRATION DATE APRIL 2014) DILUTED IN 9CC STERILE WATER AND 1CC 1% LIDOCAINE INJECTED INTO CHEEKS, MARIONETTE LINES AND JAW LINE ON (B)(6) 2011. ON ABOUT ONE YEAR LATER ( ONE MONTH AGO, (B)(6) 2012) SHE BEGAN TO DEVELOP NON TENDER NODULES AROUND MOUTH NOT VISIBLE. ON (B)(6) 2012, THE PATIENT PRESENTED TO OFFICE WITH BUMPS UNDER SKIN ON RIGHT AND LEFT CHEEKS FOR COUPLE OF WEEKS. RIGHT CHEEK INSIDE MOUTH, PUNCH BIOPSY PERFORMED AND SHE WAS DIAGNOSED WITH FOREIGN BODY GRANULOMATOUS REACTION WITH POLARIZABLE FRAGMENTS. IT IS CONSISTENT WITH PRIOR INJECTION. SHE CONTINUES TO GET MORE NODULES AROUND HER MOUTH ONLY. THERE ARE TOO MANY LESIONS TO INDIVIDUALLY INJECT WITH STEROID. THE PATIENT WAS PUT ON DOXYCYCLINE 100MG TWICE A DAY FOR 3 MONTHS TO HELP RESOLVE THE ISSUE. THE OUTCOME OF THE EVENT WAS ONGOING. THE REPORTER SUSPECTED THE EVENT OF GRANULOMATOUS REACTION IN CHEEKS IS RELATED TO POLY-L-LACTIC ACID. MEDICAL HISTORY INCLUDED ALLERGY TO PENICILLIN-HIVES. CONCOMITANT MEDICATIONS INCLUDED MULTIVITAMINS AND LIDOCAINE. NO FURTHER RELEVANT INFORMATION PROVIDED. PHARMACOVIGILANCE COMMENT: INJECTION SITE NODULE AND GRANULOMA, ASSESSED AS SERIOUS, EXPECTED POSSIBLY RELATED.