Description of Event or Problem · 1
INITIAL REPORT: THIS NON-SERIOUS SPONTANEOUS CASE REPORT FROM (B)(6) REPORTED BY A NURSE ON 13-OCT-2010, UPON MEDICAL REVIEW, HAS BEEN UPGRADED TO SERIOUS BASED ON THE RECLASSIFICATION FOR THE EVENT(S) FOLLOWING ASSESSMENT UTILIZING THE COMPANY'S NEW DEVICE REPORTING TREE (B)(4). THIS CASE INVOLVES A FEMALE PATIENT WHO RECEIVED POLY-L-LACTIC ACID ON (B)(6)2009 AND (B)(6)2009, INJECTED INTO THE NASOLABIAL FOLDS, TEMPLES, CHEEK LINES, AND HANDS. POLY-L-LACTIC ACID WAS RECONSTITUTED WITH 5 ML OF STERILE WATER AND 2 ML 2% LIDOCAINE. ON (B)(6)-2010, 13 MONTHS AFTER THE LAST INJECTION, THE PATIENT DEVELOPED GRANULOMAS ON THE RIGHT TEMPLE, RIGHT CHEEK, AND BOTH HANDS. THE LESIONS, 5 ON THE RIGHT SIDE OF HER FACE, 7 ON HER RIGHT HAND, AND 4 ON HER LEFT HAND WERE 1-2 MM IN SIZE. THERE WERE NO SIGNS OF INFLAMMATION AND NO EVIDENCE OF A SYSTEMIC PROCESS. NO BIOPSY WAS PERFORMED. THERE WAS NO EVIDENCE OF PERMANENT IMPAIRMENT OF A BODY FUNCTION OR BODY STRUCTURE. RELEVANT MEDICAL HISTORY: FITZPATRICK SKIN TYPE II, NO HISTORY OF IMMUNOLOGICAL OR COLLAGEN-VASCULAR DISEASE. RELEVANT CONCOMITANT MEDICATIONS: NOT REPORTED.