Description of Event or Problem · 1
AFTER MEDICAL REVIEW OF THIS NON-SERIOUS REPORT, IT WAS DETERMINED THAT THIS REPORT SHOULD BE 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 - (B)(4). THIS CASE INVOLVES A (B)(6) FEMALE PT WHO WAS INJECTED POLY-L-LACTIC ACID (SCULPTRA) ON (B)(6) 2011 WITH DILUTION VOLUME: STERILE WATER 5 ML + LIDOCAINE 1 ML. AMOUNT INJECTED: 6 ML. BATCH NUMBER: (UNK). REGION(S), INJECTED (LEFT AND RIGHT): MARIONETTE LINES, MALAR, PARANASAL AND TEMPORAL AREAS. ROUTE OF ADMINISTRATION: INTRADERMAL. SECOND TREATMENT WAS ON AND (B)(6) 2011 WITH DILUTION VOLUME: STERILE WATER 5 ML + LIDOCAINE 1 ML. AMOUNT INJECTED: 6 MO NOS. BATCH NUMBER: (NR, EXP DATE). REGION(S) INJECTED (LEFT AND RIGHT): MARIONETTE LINES, MALAR, PARANASAL AND TEMPORAL AREAS. ROUTE OF ADMINISTRATION: INTRADERMAL. THE PT EXPERIENCED A SMALL TUMOR LOCATED IN LEFT TEMPORAL REGION ON (B)(6) 2011 SIZE OF 5 MM, PAINLESS, VISIBLE NODULES LOCATED AT LEFT TEMPORAL REGION. DETAILED INDICATION WAS REJUVENATION (LIFTING EFFECT). NO BIOPSY WAS TAKEN. THE PHYSICIAN DESCRIBED THE ADVERSE EVENT AS ONE NODULE, NOT VERY VISIBLE BUT PALPABLE. THE PT FELT UNCOMFORTABLE ABOUT THAT. THE PHYSICIAN MADE THE PT AWARE THAT THESE THINGS COULD HAPPEN AND INDICATED THAT, IN PRINCIPLE, THIS WAS NOT A PROBLEMATIC CASE. THE PHYSICIAN INDICATED THAT THE PT WAS WELL TRAINED ON PERFORMING MASSAGE HERSELF. THE PHYSICIAN STATES THAT THE ADVERSE EVENT DID NOT LEAD TO PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. THE ADVERSE EVENT LASTED MORE THAN 30 DAYS AND AT THE TIME OF THE NOTIFICATION WAS STILL PERSISTING. THE PT STATED THAT SURGICAL INTERVENTION WAS NOT REQUIRED. THE PT WAS TREATED ON (B)(6) 2011 WITH AN INTRALESIONAL INJECTION OF 0.01 ML OF TRIAMCINOLONE ACETONIDE (TRIGON). ON (B)(6) 2011 SHE WAS TREATED WITH 0.2 OF HYALURONIDASE WITH 0.2 ML OF SALINE SOLUTION ON (B)(6) 2011 AND (B)(6) 2012. NO CONCOMITANT DISEASE/MEDICATION (NOS). THE PT WAS SUBMITTED TO OTHER ESTHETIC TREATMENTS. NO PREVIOUS SIMILAR EVENTS NEITHER AFTER POLY-L-LACTIC ACID NOR WITH OTHER PRODUCTS. NO ACUTE/CHRONIC CUTANEOUS DISEASES. NO AUTOIMMUNE DISORDER, GRANULOMATOUS DISEASE, RECENT HORMONAL CHANGES OR TENDENCY TOWARDS PATHOLOGIC SCARRING. NO ALTERNATIVE ETIOLOGY FOR THE EVENT. ACCORDING TO THE REPORTER, THE PT HAD UNDERGONE COSMETIC TREATMENTS SUCH AS BOTULINUM TOXIN TYPE A (BOTOX), HYALURONIC ACID FILLERS AND FACIAL MESOTHERAPY, WITHOUT EXPERIENCING ADVERSE EVENTS UP TO THE TIME OF NOTIFICATION. CAUSAL RELATIONSHIP AS PER REPORTER: SUSPECT. LEVEL OF CAUSALITY NOT SPECIFIED. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) HAS BEEN INITIATED. (B)(4): THE PT'S AGE IS CORRECTED TO (B)(6). MORE EVENT DETAIL ADDED WITH THE PHYSICIAN OPINION ABOUT THE EVENT.