Description of Event or Problem · 1
HOLD ON (B)(6) 2013, A SPONTANEOUS REPORT WAS RECEIVED REGARDING A (B)(6) FEMALE WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER) OR RESTYLANE-L (CROSS-LINKED HYALURONIC ACID DERMAL FILLER WITH 0.3% LIDOCAINE). MEDICAL HISTORY INCLUDED AN INJECTION OF RESTYLANE ON AN UNSPECIFIED DATE IN 2007 (ALSO REPORTED AS "7 YEARS AGO" FROM THE DATE OF THE REPORT) TO AN UNSPECIFIED SITE WITHOUT PROBLEMS; THE PATIENT HAD NO OTHER MEDICAL HISTORY. THE PATIENT'S SKIN TYPE WAS FITZPATRICK I-II. CONCOMITANT MEDICATIONS INCLUDED CALCIUM AND VITAMIN D DAILY "FOREVER." ON (B)(6) 2012 (ALSO REPORTED AS "MID (B)(6) 2012"), THE PATIENT RECEIVED A "3 SYRINGE" INJECTION OF RESTYLANE OR RESTYLANE-L (SYRINGE SIZES AND VOLUME INJECTED INTO EACH SITE UNKNOWN) AND PERLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER) OR PERLANE-L (CROSS-LINKED HYALURONIC ACID DERMAL FILLER WITH 0.3% LIDOCAINE) (SYRINGE SIZES AND VOLUME INJECTED INTO EACH SITE UNKNOWN) TO THE FACE, UNDER BOTH EYES AND BILATERALLY TO THE MARIONETTE LINES AND NASOLABIAL FOLDS. PRE-PROCEDURE MEDICATIONS INCLUDED AN UNSPECIFIED NUMBING CREAM. NO ADDITIONAL PROCEDURES WERE PERFORMED AT TIME OF IMPLANTATION. ON AN UNSPECIFIED DATE IN (B)(4) 2012 (REPORTED AS "WITHIN A MONTH AFTER GETTING THE FILLERS"), AFTER IMPLANTATION OF RESTYLANE OR RESTYLANE-L, THE PATIENT STARTED TO GET "HARD BALLS" ON THE LEFT SIDE OF HER FACE UNDER THE MARIONETTE LINES AND CHIN AREA. THERE WAS ONE "HARD BALL" ON THE LEFT SIDE, TO THE LEFT OF THE PATIENT'S MOUTH. THE "HARD SPOT OR BALL" WAS NOT VISIBLE, BUT IF THE PATIENT MOVED HER CHIN OR STUCK HER TONGUE IN THAT AREA YOU COULD SEE THE BALL. ON (B)(6) 2013, THE PATIENT WENT BACK TO THE INJECTING CLINIC. THE NURSE ADVISED THAT THEY HADN'T SEEN THIS BEFORE, AND TREATED THE AREA WITH VITRASE (HYALURONIDASE). AFTER THE APPOINTMENT, THE PATIENT STARTED TO NOTICE THAT THE AREA UNDER HER RIGHT EYE WAS PROTRUDING AND HARD; IT STARTED TO FEEL LIKE IT WAS GETTING HARD AND "GOT PRETTY BIG" THE NEXT DAY. ON (B)(6) 2013, THE PATIENT WENT BACK TO THE INJECTING CLINIC FOR FOLLOW-UP. VITRASE WAS INJECTED ON THE LEFT SIDE OF THE CHIN AGAIN AND UNDER THE RIGHT EYE. AFTER THE VITRASE TREATMENT, THE AREA ON THE LEFT SIDE OF THE CHIN BROKE UP INTO 3 "HARDER BALLS." ON AN UNSPECIFIED DATE IN (B)(6) 2013 (REPORTED AS "A COUPLE OF DAYS AFTER THE TREATMENT ON (B)(6) 2013"), NEITHER OF THE AFFECTED AREAS HAD RESPONDED TO TREATMENT, AND BOTH AREAS WERE GETTING SWOLLEN. ON (B)(6) 2013, THE PATIENT NOTED THAT THE LYMPH NODE UNDER HER CHIN WAS SWOLLEN. ON (B)(6) 2013, THE PATIENT WENT BACK TO THE INJECTING CLINIC FOR FURTHER FOLLOW-UP. THE PATIENT'S RIGHT EYE WAS MORE SWOLLEN AND SHE STILL HAD 3 SMALLER "HARD BALLS" ON THE LEFT SIDE OF HER CHIN AREA. THE NURSE ADVISED THAT THIS WAS PROBABLY JUST POST SWELLING FROM THE (B)(6) 2012 AND INJECTED BOTH AREAS WITH VITRASE AGAIN. NO TESTS OR LABORATORY STUDIES WERE PERFORMED. ON (B)(6) 2013, THE PATIENT'S LEFT EYE WAS SWOLLEN AND STARTING TO GET HARD. AS OF (B)(6) 2013, THE SWELLING AND EDEMA UNDER THE EYES AND ON THE CHIN AREA, AS WELL AS THE SWOLLEN LYMPH NODE WERE ONGOING AND SEEMED TO BE "ESCALATING." THE AREAS UNDER THE PATIENT'S EYES WERE STILL HARD AND SHE STILL HAD 3 "HARD BALLS" ON THE LEFT SIDE OF HER MOUTH OR CHIN AREA. THE PATIENT WAS SCHEDULED FOR ANOTHER FOLLOW-UP APPOINTMENT ON (B)(6) 2013. THE PATIENT HAD ALSO PLACED A CALL TO HER DERMATOLOGIST AND THE PREVIOUS ESTABLISHMENT WHERE SHE HAD RESTYLANE, BUT HAD NOT HEARD BACK FROM EITHER ONE. THE LOT NUMBER AND EXPIRATION DATE FOR RESTYLANE OR RESTYLANE-L WERE UNKNOWN. ON (B)(6) 2013, ADDITIONAL INFORMATION WAS RECEIVED FROM THE INJECTING REGISTERED NURSE (RN). BASED ON THE INFORMATION RECEIVED, THE EVENT OF PYREXIA WAS ADDED AND THE CASE WAS DEEMED REPORTABLE. THE RN CONFIRMED THAT THE PATIENT RECEIVED A 1 CC INJECTION OF RESTYLANE-L FROM A 1 CC SYRINGE TO THE MALAR CHEEK, ORAL COMMISSURES AND NASOLABIAL FOLDS (ALSO REPORTED AS "AROUND THE EYES AND CHEEK PROBABLY") (SPECIFIC AMOUNTS INJECTED INTO EACH SITE UNKNOWN) VIA "STRAIGHT IN AND BOLUS" INJECTION TECHNIQUE. ON (B)(6) 2013, THE PATIENT WAS MEDICALLY EVALUATED AND DIAGNOSED WITH "PRODUCT, TISSUE TRAUMA, AND/OR POSSIBLE INFECTION." TREATMENT INCLUDED 100 UNITS OF VITRASE INJECTED INTO THE LEFT CHIN AREA. ON (B)(6) 2013, THE PATIENT WAS MEDICALLY EVALUATED AND THE EVENTS WERE SLIGHTLY IMPROVED. TREATMENT INCLUDED 110 UNITS OF VITRASE INJECTED IN TO THE LEFT CHIN AREA AND 30 UNITS INJECTED IN TO THE LEFT CHIN AREA. ON (B)(6) 2013, THE PATIENT DEVELOPED A FEVER AND SOUGHT TREATMENT FROM ANOTHER DERMATOLOGIST. THE PATIENT WAS DIAGNOSED WITH A PROBABLE BACTERIAL INFECTION AND THE DERMATOLOGIST RECOMMENDED THE PATIENT RECEIVE ANTIBIOTICS BEFORE ANY MORE FILLERS. THE PATIENT WAS STARTED ON BIAXIN (CLARITHROMYCIN) AT 500 MG TWICE DAILY FOR 10 DAYS. ON (B)(6) 2013, THE "HARD BALLS," SWELLING/EDEMA, AND LYMPH NODE SWELLING RESOLVED. AS OF (B)(6) 2013, THE RN WAS GOING TO CALL THE PATIENT FOR FOLLOW-UP ON AN UNSPECIFIED DATE. THE RN'S OPINION OF CAUSALITY WAS THAT "SHE DIDN'T KNOW" IF THE TREATMENT CAUSED THE REPORTED EVENTS. THE RN ASSESSED THE SEVERITY OF THE REPORTED EVENTS AS "MODERATE TO SEVERE." THE LOT NUMBER AND EXPIRATION DATE FOR RESTYLANE-L WERE 11534 AND DEC-2014, RESPECTIVELY. THE PATIENT ALSO REPORTED INFORMATION REGARDING 1 ADDITIONAL INJECTION OF PERLANE-L (B)(4). COMPANY COMMENT: "AREA UNDER MY RIGHT EYE WAS PROTRUDING" IS ASSESSED AS CUSTOMER DISSATISFACTION, WHICH IS NOT AN ADVERSE EVENT.