Description of Event or Problem · 1
ON 01-APR-2011, A SPONTANEOUS REPORT BY A PHYSICIAN WAS RECEIVED FROM A COMPANY REP VIA ANOTHER MFR (REFERENCE NUMBER (B)(4)) REGARDING A (B)(6) MALE, WHO RECEIVED AN INJECTION OF PERLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). MEDICAL HISTORY INCLUDED PREVIOUS INJECTION OF BOTOX (ONABOTULINUMTOXINA) WITH NO ISSUE; THE PT'S OTHER MEDICAL HISTORY WAS UNK. THE PT'S SKIN TYPE WAS NOT REPORTED. CONCOMITANT MEDICATIONS INCLUDED NORVASC (AMLODIPINE BESYLATE), CLARITIN (LORATIDINE) AND SAM-E (S-ADENOSYL METHIONINE). THE PT RECEIVED A 1 CC INJECTION OF PERLANE ON (B)(6) 2010 TO THE NASOLABIAL FOLDS. NO PRE-PROCEDURE MEDICATIONS WERE USED. ADD'L PROCEDURES PERFORMED AT THE TIME OF IMPLANTATION INCLUDED A 90 UNIT INJECTION OF DYSPORT (ABOBOTULINUMTOXINA) TO THE GLABELLA AND HORIZONTAL FOREHEAD LINES/WRINKLES (AMOUNT INJECTED INTO EACH SITE UNK). THIS WAS THE PT'S FIRST TIME USING DYSPORT. ON AN UNSPECIFIED DATE IN (B)(6) 2010, ABOUT FIVE DAYS AFTER THE IMPLANTATION, THE PT BEGAN TO EXPERIENCE RIGHT UPPER EYELID DROOPINESS. THE PT'S FRIENDS AND THE INJECTING PHYSICIAN COULD NOT SEE THE DROOP. THE PT EXPERIENCED FLU-LIKE SYMPTOMS, NAUSEA, VERTIGO AND DULL, THROBBING HEADACHES. THE PT DID NOT EXPERIENCE VOMITING. THE PHYSICIAN AGREED TO EVALUATE THE PT BECAUSE THE PHYSICIAN USED TO BE A NEUROLOGIST. ON (B)(6) 2010, THE PT'S NEUROLOGICAL EXAM WAS NORMAL. THE EVENTS WERE STILL PRESENT, BUT TO A LESSER DEGREE AND INTERMITTENT. THE PT DID NOT SEEK ANY OTHER MEDICAL EVAL AND NO TREATMENT WAS PROVIDED FOR THE EVENTS. THE PHYSICIAN DID NOT KNOW WHAT CAUSED THE REPORTED EVENTS. THE PHYSICIAN ASSESSED THE SEVERITY OF THE REPORTED EVENTS AS MILD. THE LOT NUMBER AND EXPIRATION DATE WERE NOT REPORTED.