Description of Event or Problem · 1
THIS SPONTANEOUS CASE WAS RECEIVED ON 09/29/2014 FROM A CONSUMER AND A (B)(6) FEMALE PATIENT (PATIENT IS A PHYSICIAN). THE PATIENT HAD NO HISTORY OF ALLERGIES, AND HAD NO PRIOR PROBLEMS WITH SCULPTRA TREATMENTS. IT WAS REPORTED THAT THE PATIENT HAS RECEIVED FIVE OR SIX TREATMENTS WITH SCULPTRA AESTHETIC IN THE PAST AND DID NOT HAVE ANY ADVERSE REACTIONS. CONCOMITANT MEDICATIONS WERE NOT REPORTED. IT WAS REPORTED THAT THE PATIENT USED RESTYLANE L AND THE EVENTS ASSOCIATED WAS CAPTURED IN CASE (B)(4). ON (B)(6) 2014, THE PATIENT STARTED TREATMENT WITH SCULPTRA, IN THE FORM OF POLY-L-LACTIC ACID INJECTION, FOR AN UNKNOWN INDICATION. THE BATCH NUMBER USED WAS 1A3071. EXPIRATION DATE WAS LISTED AS 09/2016. IT WAS REPORTED THAT THE SCULPTRA WAS PREPARED AND DILUTED WITH 7 ML OF SWFI (STERILE WATER FOR INJECTION) AND 2 ML OF LIDOCAINE 1%. ON (B)(6) 2014, 30 MINUTES INTO THE TREATMENT (ONE SIDE OF HER FACE COMPLETED) WITH SCULPTRA AESTHETIC, THE PATIENT'S EARS BEGAN TO ITCH AND BECAME VIVID RED. WHILE THE PATIENT WAS STILL IN THE MIDDLE OF RECEIVING THE TREATMENT, SHE ALSO DEVELOPED HIVES ALL OVER HER BODY. THE PATIENT WAS GIVEN BENADRYL IV 50MG TO TREAT THE SYMPTOMS AND WAS ABLE TO HAVE THE TREATMENT COMPLETED WITH A GREAT DECREASE IN THE HIVES. THE PATIENT'S SYMPTOMS SLOWLY RESOLVED AFTER THE ADMINISTRATION OF BENADRYL. THE REMAINING HIVES RESOLVED OVER THE NEXT 36 HOURS. AT THE TIME OF THE REPORT, THE PATIENT WAS BACK TO NORMAL. NO ADDITIONAL INFORMATION WAS AVAILABLE. THE REPORTER STATED THAT THE CAUSALITY IS REASONABLY POSSIBLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS CASE IS CROSS-REFERENCED TO (B)(4).