Description of Event or Problem · 1
ON (B)(6) 2011, A SPONTANEOUS REPORT BY A PHYSICIAN WAS RECEIVED FROM A COMPANY REPRESENTATIVE VIA FAX, REGARDING A (B)(6) FEMALE WHO RECEIVED INJECTIONS OF RESTYLANE-L (CROSS-LINKED HYALURONIC ACID DERMAL FILLER WITH 0.3% LIDOCAINE) AND PERLANE-L (CROSS-LINKED HYALURONIC ACID DERMAL FILLER WITH 0.3% LIDOCAINE). MEDICAL HISTORY INCLUDED "TREATED THREE TIMES PRIOR TO CURRENT REACTION" (EXACT TREATMENT UNSPECIFIED. THE PATIENT'S SKIN TYPE AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT RECEIVED INJECTIONS OF RESTYLANE-L AND PERLANE-L ON AN UNSPECIFIED DATE IN (B)(6) 2011 TO THE NASOLABIAL FOLDS (REPORTED AS "NLF"). PRE-PROCEDURE MEDICATIONS AND ADDITIONAL PROCEDURES PERFORMED AT THE TIME OF IMPLANTATION WERE NOT REPORTED. ON AN UNKNOWN DATE, AFTER THE INJECTION, THE PATIENT DEVELOPED A PERSISTENT REACTION TO "RESTYLANE/PERLANE". AS OF (B)(6) 2011, THE PATIENT HAD PRESENTED TO THE PHYSICIAN'S OFFICE THREE TIMES WITH NODULES IN THE CHEEK. NO ADDITIONAL INFORMATION WAS REPORTED. ON (B)(6) 2011, ADDITIONAL INFORMATION WAS RECEIVED FROM THE COMPANY REPRESENTATIVE VIA TELEPHONE. MEDICAL HISTORY INCLUDED THREE PREVIOUS INJECTIONS OF RESTYLANE-L AND PERLANE-L TO THE NASOLABIAL FOLDS AND CHIN WITHOUT ADVERSE REACTIONS; THE PATIENT HAD NO HISTORY OF ANAPHYLAXIS. THE PATIENT'S SKIN TYPE AND CONCOMITANT MEDICATIONS WERE UNKNOWN. THE PATIENT RECEIVED INJECTIONS OF RESTYLANE-L AND PERLANE-L ON (B)(6) 2011 TO THE NASOLABIAL FOLDS AND CHIN (AMOUNT INJECTED AND TECHNIQUE USE WERE UNKNOWN). THE PATIENT DID NOT RECEIVE ANY PRE-PROCEDURE MEDICATIONS. ADDITIONAL PROCEDURES PERFORMED AT TIME OF IMPLANTATION WERE UNKNOWN. THE REPORTER STATED THAT ON (B)(6) 2011, 13 DAYS AFTER IMPLANTATION, THE PATIENT PRESENTED TO THE CLINIC WITH A NODULE IN THE LEFT CHEEK AND WAS TREATED WITH VITRASE (HYALURONIDASE). IT WAS UNKNOWN IF THE NODULE IMPROVED AFTER TREATMENT. THE PATIENT PRESENTED TO THE CLINIC AGAIN ON (B)(6) 2011 AND ON (B)(6) 2011 WITH THE SAME NODULE, MEASURING 2 TO 3 CM IN SIZE. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS AND CORTISONE INJECTIONS DURING BOTH VISITS. THE LOT NUMBER AND EXPIRATION DATE FOR BOTH RESTYLANE-L AND PERLANE-L WERE UNKNOWN. ON (B)(6) 2011, ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN. MEDICAL HISTORY INCLUDED PREVIOUS INJECTION WITH BOTH RESTYLANE-L AND PERLANE-L ON THREE SEPARATE OCCASIONS WITHOUT EVENT. THE PATIENT'S SKIN TYPE WAS UNKNOWN. CONCOMITANT MEDIATIONS INCLUDED UNSPECIFIED VITAMINS AND SUPPLEMENTS. ON (B)(6) 2011 (NOT "(B)(6) 2011", AS PREVIOUSLY REPORTED), THE PATIENT RECEIVED A 0.5 ML INJECTION OF PERLANE-L TO EACH NASOLABIAL FOLD, WITH THE SAME SYRINGE USED FOR EACH SIDE, AND A 1 ML INJECTION OF RESTYLANE-L TO THE CHIN AREA. THE PATIENT DID NOT RECEIVE AND PRE-PROCEDURE MEDICATIONS AND NO ADDITIONAL PROCEDURES WERE PERFORMED AT THE TIME OF IMPLANTATION. THE PHYSICIAN REPORTED THAT ON (B)(6) 2011, MORE THAN THREE WEEKS AFTER IMPLANTATION, THE PATIENT DEVELOPED A LARGE, RED NODULE ON THE LEFT NASOLABIAL AREA. ON (B)(6) 2011, THE PATIENT WAS PHYSICALLY EVALUATED BY THE PHYSICIAN AND RECEIVED A 1 ML INJECTION OF VITRASE. BY (B)(6) 2011, THE PATIENT NOTED "MUCH IMPROVEMENT"; BY (B)(6) 2011, THE PATIENT WAS MUCH BETTER; AND BY (B)(6) 2011, THE NODULE HAD COMPLETELY RESOLVED. ON (B)(6) 2011, THE PATIENT AGAIN NOTED REDNESS AND INFLAMMATION IN THE LEFT NASOLABIAL AREA. THE PATIENT WAS INJECTED WITH CORTISONE ON (B)(6) 2011, AND THE REDNESS AND INFLAMMATION APPEARED TO "GO DOWN". ON (B)(6) 2011, THE PATIENT DEVELOPED A BIG, RED NODULE AGAIN. THE PHYSICIAN TREATED THE PATIENT WITH AN INTRAMUSCULAR (IM) INJECTION OF KENALOG (TRIMANCINOLONE) WITH OMNICEF (CEFDINIR) 300 MG ORALLY TWICE A DAY FOR TEN DAYS. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PHYSICIAN'S OPINION OF CAUSALITY WAS THAT THE PERLANE-L CAUSED THE EVENTS. THE PHYSICIAN ASSESSED THE SEVERITY OF THE EVENTS AS SEVERE. THE LOT NUMBER AND EXPIRATION DATE FOR PERLANE-L WERE 11057 AND (B)(6) 2012, RESPECTIVELY, AND THE LOT NUMBER AND EXPIRATION DATE FOR RESTYLANE-L WERE 11069 AND (B)(6) 2012, RESPECTIVELY.