Description of Event or Problem · 1
AFTER MEDICAL REVIEW, THIS NON-SERIOUS REPORT HAS BEEN UPGRADED TO SERIOUS BASED ON THE RECLASSIFICATION FOR THE EVENT FOLLOWING ASSESSMENT UTILIZING THE COMPANY'S NEW DEVICE REPORTING TREE. THIS CASE WAS REPORTED ON (B)(6) 2012 BY A PHYSICIAN - LOCAL REFERENCE (B)(4). THIS CASE INVOLVES A (B)(6) FEMALE, TREATED WITH POLY-L-LACTIC ACID (SCULPTRA) BY SUBDERMAL INJECTION (BATCH 1A00376, EXPIRATION DATE 2013) FOR AN UNK INDICATION. POLY-L-LACTIC ACID WAS RECONSTITUTED WITH 5 ML OF STERILE WATER + 1 ML OF LIDOCAINE. INJECTIONS SITES INCLUDED THE LEFT AND RIGHT MARIONETTE LINES, CHEEKS, CHEEKBONES AND TEMPORAL. ON (B)(6) 2011, APPROX 7 MONTHS AFTER TREATMENT WITH POLY-L-LACTIC ACID, THIS PT EXPERIENCED SEVERAL VISIBLE NODULES ON THE CHEEKS. SOME NODULES WERE DESCRIBED AS MEDIUM/SMALL ON THE CHEEKBONES AND OTHERS, AS BIG, ON THE LATERAL MOUTH. CORRECTIVE TREATMENT INCLUDED CORTICOSTEROIDS AND MEDIUM FREQUENCY ULTRASOUND RADIO FREQUENCY. THE NODULES HAVE LASTED MORE THAN 30 DAYS. THE PHYSICIAN DID NOT KNOW IF THE ADVERSE EVENT WOULD LEAD TO PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. NO BIOPSY WAS PERFORMED. IT WAS NOT REPORTED IF ANY SURGICAL INTERVENTION WAS REQUIRED. ALTERNATIVE ETIOLOGY FOR THE EVENT IS UNK. THE OUTCOME OF THE EVENT AT THE TIME OF THIS REPORT WAS RECOVERING. IT WAS NOTED THAT THE PT WAS PREVIOUSLY SUBMITTED TO OTHER AESTHETIC TREATMENTS AND NO PREVIOUS SIMILAR EVENTS NEITHER AFTER POLY-L-LACTIC ACID NOR WITH OTHER PRODUCTS WAS EXPERIENCED. NO ACUTE/CHRONIC CUTANEOUS DISEASES. NO PREVIOUS GRANULOMATOUS DISEASE, RECENT HORMONAL CHANGES OR TENDENCY TOWARDS PATHOLOGIC SCARRING. THE PT'S CHILDREN HAVE INTESTINAL AUTOIMMUNE DISEASE. SIGNIFICANT/RELEVANT MEDICAL HISTORY INCLUDES AUTOIMMUNE DISORDER. NO CONCOMITANT MEDICATIONS ARE BEING ADMINISTERED. ACTION TAKEN: UNK. CORRECTIVE TREATMENT: CORTICOSTEROIDS AND MEDIUM FREQUENCY ULTRASOUND RADIO FREQUENCY. OUTCOME: RECOVERING/RESOLVING. PTC RESULTS ARE PENDING.