Description of Event or Problem · 1
(B)(4). INITIAL INFO FOR THIS SPONTANEOUS REPORT WAS REC'D FROM A HEALTH CARE PROFESSIONAL ON (B)(6) 2008: A CURRENTLY (B)(6) MALE FIRST REC'D POLY-L-LASTIC ACID [SCULPTRA] INJECTIONS IN (B)(6) 2005, FOR COSMETIC (PERIORBITAL] PURPOSE. POLY-L-LACTIC ACID WAS RECONSTITUTED WITH 3CC OF 1% LIDOCAINE, 2CC OF STERILE WATER, AND .25CC OF RECONSTITUTED POLY-L-LACTIC ACID (LOT #A406 WITH EXPIRATION 04/2006,) WAS GIVEN FOR INJECTIONS. IN (B)(6) 2005, PT PRESENTED WITH 2 TO 3 SMALL 1-2 MM NODULES UNDER HIS LEFT EYE AND 4 TO 5 NODULES UNDER HIS RIGHT EYE AND UNDER HIS TEAR TROUGH, "POSSIBLE GRANULOMAS." POLY-L-LACTIC ACID TREATMENT DOES NOT CONTINUE. HE WAS TREATED WITH SEVERAL TRIAMCINOLONE [KENALOG] INJECTIONS AND LASER TREATMENTS OVER PAST 2 YEARS. ONSET DATE OF EVENT WAS REPORTED AS (B)(6) 2005. AT THE TIME OF THE REPORT, THE NODULES HAD NOT RESOLVED. THERE WERE NO CONCOMITANT MEDS. HE HAD NO REPORTED MED HISTORY. NO FURTHER MED INFO PROVIDED. ADDENDUM FOR ADD INFO REC'D (B)(6) 2008, FROM REPORTING NURSE PRACTITIONER: (B)(6) CALLED REPORTER: REPORTER STATED THAT THE PT HAD NODULES AT FIRST (POLY-L-LACTIC ACID [SCULPTRA] INJECTED 2 YEARS AGO.) THE NODULES THAT TOOK ABOUT A YEAR TO RESOLVE. THE PT THINKS HE HAS "POKE HOLES" FROM POLY-L-LACTIC ACID WHERE IT WAS ADMINISTERED UNDER HIS EYES. THE NURSE PRACTITIONER SAID THAT THEY ARE HIS PORES. POLY-L-LACTIC ACID WAS ONLY INJECTED UNDER HIS EYES. SHE WAS NOT SURE OF THE DETAILS REGARDING RECONSTITUTION OR OTHER DETAILS WITHOUT THE CHART. NO FURTHER INFO PROVIDED. ADDENDUM FOR ADDITIONAL INFO FOR POLY-L-LACTIC ACID (SCULPTRA) FROM (B)(6) FOR (B)(4), DATED (B)(4) 2008, REC'D BY (B)(6), (B)(4) 2008 (ENTERED OUT OF SEQUENCE.) THE LOT NUMBER PROVIDED, LOT #A406, IS INVALID. ADDITIONAL INFO FOR POLY-L-LACTIC ACID (SCULPTRA) (LOT #/EXPIRATION DATE UNK) FROM PRODUCT TECHNICAL COMPLAINT REPORT CASE ID (B)(4). DATE (B)(6) 2008, REC'D BY (B)(6) ON (B)(4) 2008: BATCH RECORD REVIEW WAS WITHOUT HINT TO ROOT CAUSE. SINCE NO LOT # AVAILABLE, AN INVESTIGATION HAS BEEN PERFORMED ON THE DOCUMENTATION OF ALL POTENTIALLY INVOLVED MANUFACTURED BATCHES. THE REVIEW OF THE DEVICE HISTORY REPORTS (DHR) AND OF THE ANALYTICAL RESULTS OF THESE BATCHES DID NOT SHOW ANY ANOMALY THAT COULD BE RELATED TO THE EVENT WHICH OCCURRED. THE INVESTIGATION RESULTS SHOW THAT THIS KIND OF EVENT IS NOT BATCH RELATED. NO FAULTS, DEFECTS, DAMAGES DETECTABLE. CONCLUSION: NO FAULTS DETECTABLE. ADDITIONAL INFO REC'D (B)(4) 2008, FROM REPORTER VIA QUESTIONNAIRE: AGE, DATE OF BIRTH, HEIGHT (APPROX. (B)(6)) AND WEIGHT (APPROX (B)(6)) PROVIDED. DATE OF POLY-L-LACTIC ACID INJECTIONS: (B)(6) 2005; LOT # FOR POLY-L-LACTIC ACID CORRECTED TO A4D06/EXPIRATION DATE 04/2006. ADDITIONAL INDICATION FOR POLY-L-LACTIC ACID WAS REPORTED AS "HOLLOWNESS/FAT LOSS UNDER EYES." AMOUNT OF RECONSTITUTED POLY-L-LACTIC ACID HAS BEEN CORRECTED FROM .25CC TO 2.5 CC, TOTAL (INJECTED BELOW EYES, WITH 1.25 CC INJECTED BELOW EACH EYE.) POLY-L-LACTIC ACID TREATMENT WAS REPORTED AS GIVEN "ONE TIME ONLY." DATE OF EVENT WAS REPORTED AS (B)(6) 2005. MEDICAL HISTORY UPDATED AND INCLUDES "NASAL SURGERY" FOR AN UNREPORTED INDICATION, AND "PREVIOUS WORK" (NOS,) DONE BY OTHER SURGEONS NOT AFFILIATED WITH THEIR ORGANIZATION. ALLERGIES LISTED AS NONE. CONCOMITANT MEDS REMAIN UNK. DOCTOR PROVIDED COPIES OF PT'S PROGRESS NOTES WHICH INDICATE THE FOLLOWING: ON (B)(6) 2005, PT COMPLAINED OF (C/O) BRUISING. ON (B)(6) 2005, PT WORRIED ABOUT HIS "NASAL RIDGE" STATUS/POST SURGERY. ON (B)(6) 2005, C/O UNEVENNESS AND SWELLING. ON (B)(6) 2005, C/O LUMPS, PUFFINESS UNDER EYES, RIGHT (R). ON (B)(6) 2005, LUMPS FROM POLY-L-LASTIC ACID BELOW R EYE, INJECTED WITH TRIAMCINOLONE [KENALOG] 1:4, 0.1 CC, AND PT INSTRUCTED TO MASSAGE AREA. ON (B)(6) 2005, "KENALOG 10 TO LUMPS, SB 13/40 UNDER EYES." ON (B)(6) 2005, KENALOG TO LUMPS BELOW EYE LIDS. ON (B)(6) 2006, KENALOG TO LUMPS BELOW EYE LIDS. ON (B)(6) 2006, KENALOG TO LUMPS (SITE NOT SPECIFIED). ON (B)(6) 2006, KENALOG WITH STERILE WATER FLUSH (3 CC) TO R EYE. ON (B)(6) 2006, "KENALOG 1:5 STERILE H2O TO LUMPS, SB BELOW EYES." ON (B)(6) 2007, PT RECEIVED TREATMENT, ERBIUM 4 (?) LOWER EYES, (?) LOWER EYES, (?) LP YAG, (?) AND 1 % HYDROCORTISONE CREAM. ON (B)(6) 2007: EYES 4 (?). ON (B)(6) 2007, ERBIUM BELOW EYES. "4 TEAR DUCT, 2 SCULPTRA GRANULOMA," PT RECEIVED TREATMENT, 4 HZ/600 (?) FILTER". NOTE (B)(6), PT INDICATED THAT HE HAD "BEEN TO (B)(6) AND RECEIVED KENALOG," (DATE NOT PROVIDED.) ON (B)(6) 2008, PT WENT TO DOCTOR, C/O OF LUMPS UNDER HIS EYES "FROM SCULPTRA INJECTIONS 2 YEARS AGO." HE PRESENTED WITH 2-3 SMALL (1-2 MM) NODULES UNDER LEFT EYE AND 4-5 NODULES UNDER HIS R EYE (TEAR TROUGH) (SIZE NOT SPECIFIED.) "POSSIBLE GRANULOMAS?" "PT HAS HAD "SEV." KENALOG INJECTIONS AND LASER TX'S (ERBIUM/SMOOTH BEAM) OVER THE LAST 2 YEARS TO HIS EYES, BUT NODULES REMAIN." NO FURTHER MEDICAL INTO PROVIDED. OUTCOME OF EVENT - ONGOING. OTHER MEDICATIONS AND DISEASE STATES THAT MAY HAVE ....)