Description of Event or Problem · 1
ON (B)(6)-2011, A SPONTANEOUS REPORT BY A PHYSICIAN WAS RECEIVED FROM A COMPANY REPRESENTATIVE REGARDING A FEMALE (AGE NOT REPORTED) WHO RECEIVED AN INJECTION OF PERLANE-L (CROSS-LINKED HYALURONIC ACID DERMAL FILLER WITH 0.3% LIDOCAINE). MEDICAL HISTORY, THE PATIENT'S SKIN TYPE, AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT RECEIVED A 1 ML INJECTION OF PERLANE-L ON AN UNKNOWN DATE TO THE MALAR AREA. PRE-PROCEDURE MEDICATIONS WERE REPORTED AS UNKNOWN. ADDITIONAL PROCEDURES PERFORMED AT TIME OF IMPLANTATION WERE REPORTED AS THE REPRESENTATIVE "THOUGHT JUST PERLANE-L WAS THE ONLY PROCEDURE PERFORMED." ON AN UNKNOWN DATE (REPORTED AS "ABOUT 4-5 DAYS AFTER THE INJECTION OF PERLANE-L"), THE PATIENT CALLED THE INJECTING OFFICE AND WAS EXPERIENCING PAIN AND SWELLING IN HER CHEEKS, TOOTH PAIN, AND SWOLLEN LYMPH NODES IN HER NECK. ON AN UNKNOWN DATE, THE PATIENT WAS MEDICALLY EVALUATED BY HER PRIMARY CARE PHYSICIAN WHO THEN CALLED THE DERMATOLOGIST THAT PERFORMED THE INJECTION OF PERLANE L. TREATMENT FOR THE EVENTS WERE REPORTED AS UNKNOWN. THE PATIENT WAS TO BE EVALUATED FOR THE SYMPTOMS ON (B)(6)-2011 BY THE DERMATOLOGIST, WHO REPORTED THE PATIENT WAS BREASTFEEDING AND WONDERED IF HE SHOULD USE VITRASE (HYALURONIDASE) TO HELP WITH THE SYMPTOMS OR IF IT WOULD EXACERBATE THE SITUATION. AS OF (B)(6)-2011, THE EVENTS WERE ONGOING. THE LOT NUMBER AND EXPIRATION DATE FOR PERLANE-L WERE REPORTED AS UNKNOWN. ADDITIONAL INFORMATION FROM THE REPORTING PHYSICIAN HAS BEEN REQUESTED.