Description of Event or Problem · 1
INITIAL INFO WAS RECEIVED FROM A CONSUMER ON (B)(6) 2011 AND ADDITIONAL INFORMATION WAS REPORTED BY CONSUMER ON (B)(6) 2011. A CURRENTLY (B)(6) MALE PT WHO INITIATED TREATMENT WITH POLY-L-LACTIC ACID (SCULPTRA) (NO LOT NUMBER OR EXPIRATION DATE WAS PROVIDED) FOR FACIAL WASTING HAD HIS FIRST INJECTION 2-3 YEARS AGO TO HIS CHEEK. HIS SECOND INJECTION WAS AT LEAST 6 MONTHS LATER. THE CONSUMER STATED THAT HIS PHYSICIAN USED "1 VIAL BETWEEN BOTH CHEEKS" DURING THE FIRST TWO TREATMENTS. THE PT HAS HAD OTHER TREATMENTS TO SAME AREA SINCE, AROUND EVERY 6 TO 8 MONTHS, WITH THE LAST TREATMENT ON (B)(6) 2011. AS PER REPORTER, THE PHYSICIAN USED 1 VIAL TO EACH CHEEK DURING THE LAST COUPLE OF TREATMENTS. THE CALLER SAID THE AREA UNDER HIS CHEEK, WHERE HE HAD SCULPTRA INJECTED, HAS LUMPS. HE GOT THESE LUMPS AFTER THE FIRST TWO TREATMENTS, 2-3 YEARS AGO AND THEY HAVE NOT GONE AWAY. THE LUMPS ARE A LITTLE BIGGER THAN "PEA SIZE". THEY ARE "NOT REALLY VISIBLE" AND THERE ARE A "COUPLE OF LUMPS IN TOTAL WHICH HE STILL HAS". THERE ARE NO SIGNS OF INFLAMMATION. HE HAS NOT HAD ANY TREATMENT FOR THE LUMPS (NO MEDICAL OR SURGICAL INTERVENTION HAS BEEN PERFORMED), NO BIOPSY WAS PERFORMED, AND THERE WAS NO EVIDENCE OF A SYSTEMATIC PROCESS. MEDICAL HISTORY REPORTED AS (B)(6). NO CONCOMITANT MEDICATIONS WERE REPORTED. NO FURTHER RELEVANT INFO WAS REPORTED.