Description of Event or Problem · 1
INITIAL INFORMATION REC'D FROM A CONSUMER ON (B)(6) 2011: A (B)(6) MALE REC'D HIS FIRST SESSION OF TWO TREATMENTS OF AN UNSPECIFIED DOSE OF POLY-L-LACTIC ACID (SCULPTRA) [LOT # AND EXPIRATION DATE NOT PROVIDED] ON (B)(6) 2011 FOR LIPOATROPHY. THE CONSUMER INITIALLY CONTACTED THE COMPANY CONCERNED ABOUT HIS TWO POLY-L-LACTIC ACID INJECTIONS BECAUSE HE THINKS HE DID NOT GET THE ENTIRE SECOND DOSE. HE STATED THAT HIS PHYSICIAN ADMINISTERED ABOUT 8 INJECTIONS IN THE RIGHT CHEEK AND ONLY 4 INJECTIONS IN THE LEFT CHEEK. HE THEN STATED AT THE TIME OF THE INJECTION ON (B)(6) 2011, HE EXPERIENCED TINGLING AND NUMBNESS IN THE RIGHT CHEEK. THE CONSUMER STATED HE DID NOT FEEL ANY TINGLING OR NUMBNESS IN THE LEFT CHEEK WHEN THE INJECTIONS WERE GIVEN AND FEELS HE DID NOT GET ANY OF THE POLY-L-LACTIC ACID IN THE LEFT CHEEK. HE STATED HIS PHYSICIAN TOLD HIM THE SYRINGE CLOGGED AND HE COULD NOT GIVE ANY MORE INJECTIONS. HE MENTIONED HE CAN FEEL THE POLY-L-LACTIC ACID IN HIS RIGHT CHEEK, BUT NOT IN THE LEFT CHEEK. CONCOMITANT MEDICATIONS AND MEDICAL HISTORY WERE NOT PROVIDED. AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENTS WAS NOT PROVIDED AND THE CONSUMER IS TO RETURN TO THE PHYSICIAN ON (B)(6) 2011 FOR THE NEXT INJECTIONS. NO FURTHER RELEVANT INFORMATION REPORTED. ADDITIONAL INFORMATION REC'D FROM A CONSUMER ON (B)(6) 2011 (UPON MEDICAL REVIEW OF THE ADDITIONAL INFORMATION REC'D, THIS PREVIOUSLY REPORTED NON-SERIOUS CASE HAS BEEN UPGRADED TO SERIOUS BASED ON THE RECLASSIFICATION FOR THE EVENT(S) FOLLOWING ASSESSMENT UTILIZING THE COMPANY'S NEW DEVICE REPORTING TREE). THE CONSUMER REPORTED THAT HE REC'D HIS LAST INJECTION OF POLY-L-LACTIC ACID TWO DAYS AGO ((B)(6) 2011) AND THAT HE IS ONLY GETTING THE EFFECTS OF THE POLY-L-LACTIC ACID ON ONE SIDE OF HIS FACE. THE CONSUMER ALSO STATED THAT THE "LEFT SIDE LOOKS DEFORMED." HE REPORTED THAT HE "FEELS THE NEEDLE AND SWELLING", BUT IT IS "NOT WORKING AND HE IS DEVASTATED." NO FURTHER RELEVANT INFORMATION REPORTED.