Description of Event or Problem · 1
INITIAL REPORT: THIS NON-SERIOUS SPONTANEOUS CASE REPORT FROM (B)(6) WAS RECEIVED FROM A NURSE ON (B)(6) 2010 AND 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 IS ASSOCIATED TO CASE: (B)(6) BY REPORTER. THIS CASE INVOLVES A FEMALE PT (AGE UNK) WHO RECEIVED HER FIRST TREATMENT OF POLY-L-LACTIC ACID (SCULPTRA) ON (B)(6) 2010. SHE RECEIVED ONCE VIAL WHICH WAS INJECTED IN THE CHEEKS, SIDE OF MOUTH AND CHIN LINE (BATCH NUMBER: A8028, EXP DATE: NOV-2010). AFTER THIS TREATMENT, DATE UNK, SHE EXPERIENCED SLIGHT BLURRED VISION. SHE RECEIVED A SECOND TREATMENT ON (B)(6) 2010. SHE RECEIVED ONE VIAL WHICH WAS INJECTED IN THE CHEEKS, SIDE OF MOUTH, AND CHIN LINE (BATCH NUMBER USED: 1A0034. EXP DATE: DEC-2011). ON AN UNK DATE, THE PT EXPERIENCED A RASH ON HER NECK AND BLURRED VISION. THE RASH IS A PIN-PRICK RASH AND WAS VERY ITCHY. THE PT WAS PRESCRIBED STEROIDS AS CORRECTIVE THERAPY FOR THE RASH. NO FURTHER INFORMATION WAS PROVIDED REGARDING THE EVENT OF BLURRED VISION. RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATION INFORMATION WERE NOT MENTIONED. OUTCOME - UNK. A PTC (PHARMACEUTICAL TECHNICAL COMPLAINT) WAS INITIATED: (B)(4). THE NURSE REPORTED THAT SHE DOES NOT FEEL THAT THE REACTION OF RASH WAS DUE TO POLY-L-LACTIC ACID AS THE RASH WAS LOCATED ON THE PT'S NECK, AND THE PT WAS NOT TREATED IN THIS AREA. SIGNIFICANT CORRECTION DATED (B)(6) 2010: UPON INTERNAL REVIEW, IT WAS DISCOVERED THAT THE FOLLOWING INFORMATION WAS OMITTED FROM THE INITIAL REPORT: TOPICAL ANESTHETIC AND LIDOCAINE WERE USED PRIOR TO INJECTION. ALSO, "VERY ITCH" HAS BEEN ADDED AS A SYMPTOM OF THE PT'S RASH. PHARMACOVIGILANCE COMMENT: SANOFI-AVENTIS COMPANY COMMENT DATED (B)(6) 2010: THIS CASE INVOLVING A FEMALE PT OF UNK AGE WHO REPORTEDLY DEVELOPED SLIGHT BLURRED VISION AFTER THE FIRST SCULPTRA INJECTION WITH RECURRENCE OF BLURRED VISION AFTER THE SECOND INJECTION LACKS SUFFICIENT INFORMATION FOR A THOROUGH MEDICAL ASSESSMENT. ADDITIONAL INFORMATION INCLUDING DETAILS OF SUSPECT DRUG ADMINISTRATION (INDICATION, VOLUME ADMINISTERED, RECONSTITUTION TECHNIQUE), PT'S MEDICAL HISTORY (INCLUDING ANY HISTORY OF EYE PROBLEMS AND USE OF CORRECTIVE LENSES) AND CONCOMITANT MEDICATIONS, CHRONOLOGICAL DETAILS OF THE EVENTS, PERTINENT DIAGNOSTIC EXAM FINDINGS (INCLUDING GLUCOSE LEVEL, ANA, SEDIMENTATION RATE), WHETHER OR NOT OTHER CAUSES OF BLURRED VISION WERE EXCLUDED (INCLUDING UNCORRECTED VISION DISORDER, DRY EYES, CATARACTS, GLAUCOMA, MACULAR DEGENERATION, IRITIS, ETC.), DETAILS OF CORRECTIVE TREATMENT PROVIDED FOR THE PT'S BLURRED VISION, AND FINAL OUTCOME IS NEEDED FOR A COMPLETE EVALUATION OF THIS CASE.