Description of Event or Problem · 1
INITIAL INFO REPORTED BY A PHYSICIAN TO A SALES REP ON (B)(6) 2010: A FEMALE IN HER 40'S INITIATED TREATMENT WITH INJECTABLE POLY-L-LACTIC ACID (SCULPTRA) (LOT # AND EXP DATE UNK) ON AN UNK DATE. ON (B)(6) 2010, SHE WAS SEEN BY A DIFFERENT DR FOR THE FIRST TIME. SHE COMPLAINED OF A LARGE RAISED BUMP AT THE SITE OF THE INJECTION WHICH IS NEAR THE LOWER CHEEK MOUTH AREA ON BOTH SIDES OF HER FACE THAT WOULD SPORADICALLY COME AND GO. WHEN SHE WOULD PRESS ON THE BUMP, LIQUID WOULD COME OUT THAT WAS CLEAR AND SOMETIMES FILLED WITH MUCUS. ON (B)(6) 2010, SHE CONTACTED THE DR AGAIN TO SAY THAT THE BUMPS HAD REAPPEARED. THE PHYSICIAN HAD NOT SEEN THE BUMPS THAT THE PT HAD DESCRIBED BUT SHE HAD TAKEN PICTURES OF HERSELF TRYING TO REPRODUCE WHAT HAPPENS TO HER BY PUSHING HER TONGUE ON THE INSIDE OF HER CHEEK TO REPRESENT THE BUMP AND THEN PRESSING THE BUMP. THE PHYSICIAN DID NOT KNOW IF THE PT WAS ALLERGIC TO INJECTABLE POLY-L-LACTIC ACID NOR DID SHE KNOW IF THE PT HAD RECEIVED OTHER FILLERS IN THE PAST. THE PHYSICIAN ADVISED THAT SHE HAS NOT TREATED THE PT BECAUSE, SHE DID NOT KNOW WHAT SHE WAS DEALING WITH, DIDN'T KNOW WHAT THE PT HAD BEEN GIVEN BY WAY OF INJECTABLE POLY-L-LACTIC ACID AND ALSO BECAUSE, SHE HAS YET TO SEE THE BUMP ISSUE. NO FURTHER RELEVANT INFO REPORTED.