Description of Event or Problem · 1
INITIAL INFORMATION RECEIVED FROM A PHYSICIAN ON (B)(6) 2011. A (B)(6) FEMALE INITIATED TREATMENT WITH POLY-L-LACTIC ACID (SCULPTRA AESTHETIC) (LOT # AND EXPIRATION DATE NOT PROVIDED) ON (B)(6) 2011, IN THE ZYGOMATIC ARCHES FOR COSMETIC PURPOSES. SHE RECEIVED 3.5 CC OF POLY-L-LACTIC ACID IN THE RIGHT CHEEK AND 3.0 CC IN THE LEFT CHEEK. THREE DAYS LATER, ON (B)(6) 2011, THE PATIENT CALLED THE REPORTER STATING THAT SHE STARTED GETTING AN ITCHY RASH ON THE LOWER HALF OF HER FACE AND UPPER NECK AREA, NOT AT THE INJECTION SITES. THE PATIENT HAD TRIED TO MANAGE THE ITCHY RASH WITH OVER-THE-COUNTER MEDICATIONS: DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL) AND LORATADINE (CLARITIN). THE REPORTER HAD TESTED THE PATIENT ON (B)(6) 2011, BEFORE HER FIRST INJECTION ON (B)(6) 2011, BY INJECTING POLY-L-LACTIC ACID ON THE RIGHT VOLAR ASPECT OF HER FOREARM AND THERE WAS NO REACTION. THE REPORTER MENTIONED THAT THE PATIENT HAD SWITCHED TO A DIFFERENT FACIAL LOTION THE DAY BEFORE SHE GOT THE RASH. THE PATIENT WAS SEEN IN THE OFFICE ON (B)(6) 2011 DUE TO THE RASH. THE PHYSICIAN HAD HER TRY THE FACIAL LOTION ON HER ARMS TO SEE IF THE RASH WOULD APPEAR. THE NEXT DAY, ON (B)(6) 2011, THE PATIENT CALLED THE PHYSICIAN BACK AND STATED THERE WAS NO RASH ON HER ARMS. HOWEVER, THE RASH ON HER LOWER FACE AND NECK WAS SPREADING. THE PATIENT WAS PRESCRIBED METHYLPREDNISOLONE (MEDROL DOSEPAK) ON (B)(6) 2011. THE PATIENT CALLED AND REPORTED THAT THE RASH WAS GETTING BETTER AFTER STARTING TREATMENT WITH METHYLPREDNISOLONE. NO SURGICAL INTERVENTION WAS PROVIDED. THERE WERE NO SIGNS OF INFLAMMATION AND THERE WERE NO NODULES/PAPULES. THE REPORTER DID NOT EXPECT THE EVENTS TO BE IRREVERSIBLE. THERE WAS NO EVIDENCE OF PERMANENT IMPAIRMENT OF A BODY FUNCTION OR BODY STRUCTURE. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. MEDICAL HISTORY WAS PROVIDED AS POLLEN, CAT AND DUST ALLERGIES. THE PATIENT HAD NO HISTORY OF IMMUNOLOGICAL OR COLLAGEN VASCULAR DISEASE. NO FURTHER RELEVANT INFORMATION REPORTED.