Description of Event or Problem · 1
INITIAL INFO REPORTED BY A PHYSICIAN TO A SALES REP ON (B)(6) 2010 AND ADD'L INFO RECEIVED FROM A NURSE ON (B)(6) 2010: A (B)(6) FEMALE CONSUMER INITIATED TREATMENT WITH INJECTABLE POLY-L-LACTIC ACID (SCULPTRA) FOR COSMETIC PURPOSES. ON (B)(6) 2010, THE PRODUCT WAS RECONSTITUTED WITH 6 CUBIC CENTIMETERS (CC) OF BACTERIOSTATIC WATER AND 2 CC OF LIDOCAINE. ON (B)(6) 2010, DURING HER FIRST SESSION, THE CONSUMER RECEIVED 2 VIALS OF INJECTABLE POLY-L-LACTIC ACID (LOT # A9029 & EXP DATE: FEBRUARY-2012) IN HER NASOLABIAL FOLDS, MARIONETTE LINES AND TEMPORAL REGIONS. ON AN UNK DATE AFTER THE INJECTION, SHE CALLED THE PHYSICIAN AND REPORTED HAVING HOLLOW BAGS UNDER HER EYES. SHE WAS SCHEDULED FOR AN APPOINTMENT BUT MISSED IT BECAUSE HER CHILD WAS SICK. HER APPOINTMENT WAS RESCHEDULED FOR (B)(6) 2010. DURING THAT APPOINTMENT, SHE HAD A LITTLE BOTULINUM TOXIN TYPE A (BOTOX) INJECTED IN ORDER TO TOUCH UP HER BROW. ON (B)(6) 2010, SHE ATTENDED A SECOND SESSION, WHERE SHE RECEIVED 1 VIAL OF INJECTABLE POLY-L-LACTIC ACID (LOT # 2A9030 & EXP DATE FEBRUARY-2012). THE EVENT REMAINED ONGOING AT THE TIME OF THIS REPORT. THE PATIENT WAS INSTRUCTED TO USE ICEPACKS AS CORRECTIVE TREATMENT. IT WAS ALSO STATED THAT THE PT HAD SEEN MULTIPLE DOCTORS REGARDING THE ADVERSE EVENT AND THESE DOCTORS, WHO WERE NOT SCULPTRA TRAINED, TOLD THE PT THAT THEY COULD FEEL THE PRODUCT UNDER HER EYES. THE RPTR STATED THAT IT IS NOT POLY-L-LACTIC ACID THAT IS UNDER HER EYES, THE PT HAD BAGS UNDER HER EYES BEFORE TREATMENT WITH SCULPTRA, AND THE ADVERSE EVENT IS MOST LIKELY DUE TO THE INTERFERON BETA (REBIF) SHE TAKES FOR HER MULTIPLE SCLEROSIS (MS). MEDICAL HISTORY INCLUDED MS AND NO KNOWN ALLERGIES. CONCOMITANT MEDICATIONS INCLUDED REBIF, BUPROPION, HYDROCHLORIDE (WELLBUTRIN), "RITLIN" AND BOTULINUM TOXIN TYPE A (BOTOX). NO FURTHER RELEVANT INFO REPORTED.