Description of Event or Problem · 1
ON (B)(4) 2013, A SPONTANEOUS REPORT BY A PHYSICIAN WAS RECEIVED FROM A COMPANY REP REGARDING A (B)(6) FEMALE WHO RECEIVED AN INJECTION OF RESTYLANE-L (CROSS-LINKED HYALURONIC ACID DERMAL FILLER WITH 0.3% LIDOCAINE). MEDICAL HISTORY, SKIN TYPE, AND CONCOMITANT MEDICATIONS WERE UNK. THE PATIENT RECEIVED AN INJECTION OF RESTYLANE-L FROM A 1 ML SYRINGE (VOLUME INJECTED NOT REPORTED) ON (B)(6) 2012 TO THE TEAR TROUGHS, PERIORAL AREA, AND MARIONETTE LINES. PRE-PROCEDURE MEDICATIONS AND ADD¿L PROCEDURES PERFORMED AT THE TIME OF IMPLANTATION WERE UNK. ON A UNSPECIFIED DATE IN (B)(6) 2012 OR (B)(6) 2013 (REPORTED AS ¿ABOUT 3 WEEKS AFTER THE INJECTION¿), THE PATIENT DEVELOPED RIGHT LOWER TEAR TROUGH SWELLING. ON AN UNSPECIFIED DATE IN 2013, THE PATIENT WAS MEDICALLY EVALUATED AT THE INJECTING CLINIC AND TREATED WITH HYALURONIDASE. ON AN UNSPECIFIED DATE IN 2013, THE PATIENT WAS EVALUATED AGAIN AT THE INJECTING CLINIC. AT THIS VISIT, IT LOOKED LIKE THERE WAS SOME SWELLING OR REDNESS IN THE MARIONETTE AREA AS WELL; THE COMPANY REP DID NOT KNOW THE DATE OF ONSET FOR THE REDNESS OR SWELLING IN THE MARIONETTE LINES. ON AN UNSPECIFIED DATE IN (B)(6) 2013 (REPORTED AS ¿THIS WEEK¿ FROM THE DATE OF THE REPORT), THE PATIENT WAS EVALUATED AT THE INJECTING CLINIC. THE COMPANY REP WAS UNSURE IF ANY TREATMENT WAS RECOMMENDED. AS OF (B)(6) 2013, THE EVENTS WERE ONGOING; THE COMPANY REP WAS UNSURE IF THE SWELLING IN THE TEAR TROUGH AREA WAS STILL PRESENT. THE LOT NUMBER AND EXPIRATION DATE FOR RESTYLANE-L WERE REPORTED AS 111229 AND UNK, RESPECTIVELY; HOWEVER, LOT NUMBER 111229 IS NOT A VALID LOT NUMBER FOR RESTYLANE-L. ON (B)(4) 2013, ADD¿L INFO WAS RECEIVED FROM THE OFFICE MANAGER FROM THE INJECTING CLINIC, WHO PROVIDED INFO FROM THE PATIENT¿S CHART. BASED ON THE INFO RECEIVED, THE FOLLOWING EVENTS WERE ADDED: IMPLANT SITE PAIN, IMPLANT SITE MASS, AND PURULENT DISCHARGE, AND THE CASE WAS UPGRADED DUE TO UNEXPECTED SEVERITY. THE PATIENT WAS FURTHER IDENTIFIED AS (B)(6). MEDICAL HISTORY INCLUDED PREVIOUS INJECTIONS OF RADIESSE (SYNTHETIC CALCIUM HYDROXYLAPATITE DERMAL FILLER) AND JUVEDERM (CROSS-LINKED HYALURONIC ACID DERMAL FILLER) ON (B)(6) 2012 TO AN UNSPECIFIED SITE WITHOUT PROBLEMS AND JUVEDERM ULTRA XC (CROSS-LINKED HYALURONIC ACID DERMAL FILLER WITH LIDOCAINE) ON AN UNSPECIFIED DATE IN (B)(6) 2012 TO THE CHEEKS WITHOUT PROBLEMS; NO ALLERGIES, ¿BENIGN MULTIPLE SCLEROSIS (MS)¿ (DIAGNOSED ON AN UNSPECIFIED DATE IN 1991), HIGH BLOOD PRESSURE, AND CHRONIC BACK PAIN. THE PATIENT¿S SKIN TYPE WAS FITZPATRICK II. CONCOMITANT MEDICATIONS INCLUDED HYDROCODONE AS NEEDED FOR CHRONIC BACK PAIN, VITAMIN E, ESTRA-C (ESTRADIOL), ATIVAN (LORAZEPAM) 1 MG DAILY, IMIPRAMINE 25 MG DAILY, AND ATACAND (CANDESARTAN CILEXETIL). THE OFFICE MANAGER CONFIRMED THAT THE PATIENT RECEIVED 1 ML INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER), NOT RESTYLANE-L AS WAS PREVIOUSLY REPORTED, ON (B)(6) 2012 TO THE TEAR TROUGHS, PERIORAL AREA, AND MARIONETTE LINES (AMOUNTS INJECTED TO EACH SITE WERE UNK). PRE-PROCEDURE MEDICATIONS INCLUDED AN UNSPECIFIED TOPICAL ANESTHETIC CREAM. NO ADD¿L PROCEDURES WERE PERFORMED AT THE TIME OF IMPLANTATION. ON AN UNSPECIFIED DATE IN (B)(6) 2012, AFTER THE IMPLANTATION, THE PATIENT DEVELOPED SIGNIFICANT ERYTHEMA, SWELLING AND PAIN TO THE RIGHT LOWER TEAR TROUGH, REDNESS AND SWELLING TO THE LEFT TEAR TROUGH AND MARIONETTE LINES, AND PALPABLE NODULES IN THE LEFT LOWER FACE AREA. ON (B)(6) 2012, THE PATIENT WAS EVALUATED BY THE INJECTING PHYSICIAN. THE PREVIOUSLY REPORTED EVENTS WERE NOTED. THERE WERE NO SIGNS OF INFECTION OR DRAINAGE TO THE AFFECTED AREAS. THE EVENTS WERE NOTED BY THE PHYSICIAN AS A ¿QUESTIONABLE INFECTION OR ALLERGIC REACTION TO RESTYLANE.¿ THE AFFECTED AREAS WERE TREATED WITH AN INJECTION OF HYALURONIDASE AND OXYCONTIN (OXYCODONE) IMMEDIATE RELEASE 5 MG ONE EVERY 6 HOURS AS NEEDED WAS PRESCRIBED. THE LEFT TEAR TROUGH SWELLING AND REDNESS RESOLVED ¿SHORTLY AFTER¿ THE HYALURONIDASE INJECTION. ON (B)(6) 2012, THE PATIENT WAS SEEN BY THE INJECTING PHYSICIAN. PURULENT DRAINAGE FROM RIGHT LOWER TEAR TROUGH WAS NOTED AND A CULTURE WAS OBTAINED, WHICH SHOWED NO BACTERIA. THE PATIENT WAS PRESCRIBED CLINDAMYCIN 300 MG FOUR TIMES DAILY FOR 7 DAYS FOR COVERAGE, IN CASE THIS WAS AN INFECTION. ON (B)(6) 2013, THE PATIENT WAS EVALUATED BY THE INJECTING PHYSICIAN; THE RESULTS OF THE VISIT WERE NOT DOCUMENTED IN THE PATIENT¿S CHART. ON (B)(6) 2013, THE PATIENT WAS EVALUATED BY THE INJECTING PHYSICIAN, AND RECURRENT ERYTHEMA AND SWELLING AT THE RIGHT TEAR TROUGH WAS NOTED; THE SITE WAS INJECTED WITH HYALURONIDASE AND ANOTHER ROUND OF CLINDAMYCIN 300 MG, FOUR TIMES DAILY FOR 7 DAYS, WAS PRESCRIBED. ON AN UNSPECIFIED DATE ¿BY (B)(6) 2013,¿ THE REDNESS AND SWELLING OF THE MARIONETTE LINES, WHICH HAD WAXED AND WANED, AS WELL AS THE PALPABLE NODULES TO THE LEFT LOWER FACE, RESOLVED. ON (B)(6) 2013, THE PATIENT WAS EVALUATED BY THE INJECTING PHYSICIAN. ERYTHEMA, SWELLING, AND PURULENT DRAINAGE FROM THE RIGHT TEAR TROUGH WERE NOTED AND ANOTHER CULTURE WAS OBTAINED, WHICH WAS NEGATIVE FOR BACTERIA. AN ADD¿L ROUND OF CLINDAMYCIN 300 MG FOUR TIMES DAILY X 7 DAYS WAS PRESCRIBED. ON (B)(6) 2013, THE PATIENT WAS EVALUATED BY THE INJECTING PHYSICIAN. REDNESS, PAIN, SWELLING, AND PURULENT DRAINAGE TO RIGHT TEAR TROUGH CONTINUED; ALL OF THE OTHER INJECTION SITES REMAINED SYMPTOM-FREE. NO TREATMENT WAS PROVIDED OR PRESCRIBED. THE PATIENT WAS REFERRED TO A DERMATOLOGIST FOR A SECOND OPINION. AS OF (B)(6) 2013, A DIAGNOSIS FOR THE EVENTS HAD NOT BEEN ESTABLISHED. NO FURTHER FOLLOW-UP WITH THE INJECTING PHYSICIAN WAS SCHEDULED; THE PATIENT CONTINUED TO FOLLOW-UP WITH DERMATOLOGY. THE INJECTING PHYSICIAN¿S OPINION OF CAUSALITY WAS THAT THE PATIENT¿S EVENTS WERE RELATED TO THE TREATMENT NOTED AS ¿QUESTIONABLE INFECTION OR ALLERGIC REACTION TO RESTYLANE.¿ THE INJECTING PHYSICIAN DID NOT NOTE THE SEVERITY OF THE EVENTS IN THE PATIENT¿S CHART. THE LOT NUMBER AND EXPIRATION DATE FOR RESTYLANE WERE 11229 AND JUN-2014, RESPECTIVELY. ON (B)(4) 2013, ADD¿L INFO WAS RECEIVED FROM THE DERMATOLOGIST. ON (B)(6) 2013, THE PATIENT WAS EVALUATED. THE AFFECTED AREA WAS ¿DRAINED¿ FOR THE FOURTH TIME, UNSPECIFIED CULTURES WERE OBTAINED, AND THE PATIENT WAS DIAGNOSED WITH ¿FUNGAL OR ATYPICAL MYCOBACTERIUM, PENDING CULTURE RESULTS.¿ THE DERMATOLOGIST FURTHER STATED THAT IT LOOKED INFECTIOUS IN NATURE, BUT HE WAS AWAITING CULTURE RESULTS. AS OF (B)(6) 2013, THE EVENTS HAD IMPROVED, AND ALL CULTURES THUS FAR HAD BEEN NEGATIVE FOR ANAEROBES AND AEROBES. NO FOLLOW-UP WAS PLANNED; THE DERMATOLOGIST PLANNED TO WAIT FOR CULTURE RESULTS BEFORE SCHEDULING FURTHER FOLLOW-UP.