Description of Event or Problem · 1
THIS CASE WAS REPORTED ON 08/10/2011 BY A PHYSICIAN - LOCAL REFERENCE (B)(4). THIS IS THE SIXTH CASE OF SIX. ASSOCIATED REPORTS: (B)(4). THIS CASE INVOLVES A (B)(6) MALE WHO WAS TREATED WITH POLY-L-LACTIC ACID (SCULPTRA) FOR COSMETIC PURPOSES TO THE HOLLOW CHEEKS AND CHEEK BONES ON (B)(6) 2008 AND (B)(6) 2009. FOR EACH TREATMENT, POLY-L-LACTIC ACID WAS RECONSTITUTED WITH 5 ML OF STERILE WATER AND 2 ML OF LIDOCAINE. ON (B)(6) 2008, DEEP DERMAL INJECTION AS ADMINISTERED WITH A FANNING TECHNIQUE. TYPE OF INJECTION AND TECHNIQUE FOR THE OTHER TWO TREATMENTS WAS NOT INDICATED. FOR ALL TREATMENTS MASSAGE WAS PERFORMED DURING TREATMENT AND THEN BY THE PATIENT. DURING A CONSULTATION ON (B)(6) 2010, THIS PATIENT MENTIONED THAT HE HAS KNOBBLES FOR THE PAST FOUR MONTHS ON THE CHEEK BONES AND CHEEKS. THE KNOBBLES WERE VERY PALPABLE AND VISIBLE. THEY WERE 4 MM IN SIZE. THE PHYSICIAN DIAGNOSED LATE GRANULOMA/NODULE FORMATION. THERE WERE NO SIGNS OF INFLAMMATION OR EVIDENCE OF A SYSTEMIC PROCESS. NO BIOPSY WAS PERFORMED. THE ADVERSE EVENT WAS NOT EXPECTED TO BE IRREVERSIBLE. A DERMATOLOGIST WAS CONSULTED ON (B)(6) 2011. AS CORRECTIVE TREATMENT, THE PATIENT RECEIVED ANTIBIOTICS NOS 6/DAY FOR FOUR WEEKS AND THEN 4/DAY FOR TWO WEEKS, AS WELL AS CORTISONE NOS INJECTION. ON (B)(6) 2011, THE KNOBBLES WERE NO LONGER VISIBLE. IT WAS NOTED THAT THIS PATIENT HAS RECEIVED TREATMENT WITH TEOSYAL (HYALURONIC ACID), BOTOX AND MESOLIFTING NOS. THESE PRODUCTS WERE ADMINISTERED TO OTHER AREAS THAN THE ONES TREATED WITH POLY-L-LACTIC ACID. THE PHYSICIAN STATED THE ADVERSE EVENT WAS NOT RELATED TO THESE PRODUCTS. SIGNIFICANT/RELEVANT MEDICAL HISTORY: NONE. RELEVANT CONCOMITANT MEDICATIONS: LIDOCAINE. ACTION TAKEN: NOT APPLICABLE. CORRECTIVE TREATMENT: ANTIBIOTICS NOS AND CORTISONE NOS INJECTION. OUTCOME: RECOVERED. A PTC (PRODUCT TECHNICAL COMPLAINT) HAS BEEN INITIATED: (B)(4).