Description of Event or Problem · 1
ON (B)(6) 2011, A SPONTANEOUS REPORT BY A PHYSICIAN WAS RECEIVED VIA FAX REGARDING A FEMALE (AGE NOT REPORTED) WHO RECEIVED AN INJECTION OF PERLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). ON (B)(6) 2011, A REPORT WAS RECEIVED VIA FAX FROM A COMPANY REPRESENTATIVE. MEDICAL HISTORY, CONCOMITANT MEDICATIONS, AND THE PATIENT'S SKIN TYPE WERE NOT REPORTED. THE PATIENT RECEIVED AN INJECTION OF PERLANE (SYRINGE SIZE AND AMOUNT INJECTED NOT REPORTED) ON AN UNKNOWN DATE TO THE CHEEKS. ON AN UNKNOWN DATE, AFTER THE IMPLANTATION, THE PATIENT EXPERIENCED INFLAMMATION ON BOTH SIDES, WITH A YELLOWISH/WHITISH SUBSTANCE INSIDE. NO FURTHER INFORMATION WAS REPORTED. ON (B)(6) 2011, FOLLOW UP INFORMATION WAS OBTAINED FROM THE INJECTING PHYSICIAN. THE PATIENT WAS 54 YEARS OLD. MEDICAL HISTORY INCLUDED "FACELIFTS" ON (B)(6) 2011, PREVIOUS INJECTIONS OF JUVEDERM (CROSS-LINKED HYALURONIC ACID DERMAL FILLER) ON UNKNOWN DATES WITHOUT ISSUES, AND A PREVIOUS INJECTION OF RADIESSE (SYNTHETIC CALCIUM HYDROXYLAPATITE DERMAL FILLER) ON AN UNSPECIFIED DATE IN (B)(6) 2011 IN CHEEKS, WITHOUT ISSUES. THE PATIENT'S SKIN TYPE WAS FITZPATRICK II. CONCOMITANT MEDICATIONS INCLUDED A DAILY MULTIVITAMIN, CALCIUM, OMEGA 3, AND VITAMIN D (DOSAGE AMOUNTS REPORTED AS UNKNOWN). THE PATIENT RECEIVED A 1 ML INJECTION OF PERLANE ON (B)(6) 2011 TO THE BILATERAL CHEEKS AND NASOLABIAL FOLDS. THE PATIENT DID NOT RECEIVE ANY PRE-PROCEDURE MEDICATIONS OR ADDITIONAL PROCEDURES PERFORMED AT TIME OF IMPLANTATION. ON (B)(6) 2011, ALMOST IMMEDIATELY AFTER THE IMPLANTATION, THE PATIENT EXPERIENCED REDNESS AND HARDNESS AT THE INJECTION SITES. ON AN UNSPECIFIED DATE IN (B)(4) 2011 (REPORTED AS "TWO WEEKS LATER" FROM (B)(6) 2011), TH INFLAMMATORY RESPONSE CONTINUED AND PEAKED; RESULTING IN INDURATIONS OF BOTH CHEEKS. ON (B)(6) 2011, THE PATIENT EXPERIENCED HER EYES "NEARLY SWELLED SHUT" AND WAS MEDICALLY EVALUATED BY ANOTHER PHYSICIAN. TREATMENT INCLUDED A SOLU MEDROL (METHYLPREDNISOLONE) DOSE PACK AND CLINDAMYCIN 300 MG 4 TIMES DAILY. ON (B)(6) 2011 AND ON (B)(6) 2011, THE PATIENT HAD FOLLOW-UP APPOINTMENTS WITH ANOTHER PHYSICIAN WHERE THERE WAS NO CHANGE IN CARE AND THE INFLAMMATION WAS IMPROVED. ON (B)(6) 2011, THE PATIENT WAS MEDICALLY EVALUATED BY THE INJECTING PHYSICIAN WHERE THERE WAS NO CHANGE IN CARE AND THE INFLAMMATION WAS IMPROVED. ON (B)(6) 2011, THE PATIENT WAS AGAIN MEDICALLY EVALUATED BY THE INJECTING PHYSICIAN. THE PHYSICIAN NOTED A DECREASE IN THE INFLAMMATION (ALSO REPORTED AS "ACUTE" INFLAMMATION) TO THE POINT WHERE FLUCTUANT, FIRM NODULES WERE VISIBLE IN BOTH CHEEKS. THE PHYSICIAN ASPIRATED THE NODULES AND SENT THE FLUID TO BE CULTURED, WHICH SHOWED "STERILE ABSCESSES." THE PATIENT WAS ALSO INJECTED WITH AN UNSPECIFIED AMOUNT OF VITRASE (HYALURONIDASE). ON (B)(6) 2011, THE PATIENT RETURNED TO THE INJECTING PHYSICIAN FOR A FOLLOW UP APPOINTMENT. THE PHYSICIAN AGAIN ASPIRATED THE NODULES (ALSO REPORTED AS "STERILE ABSCESSES") AND INJECTED MORE VITRASE (AMOUNT INJECTED NOT REPORTED). ON (B)(6) 2011, THE PATIENT RETURNED TO THE INJECTING PHYSICIAN FOR ANOTHER FOLLOW UP APPOINTMENT. THE INFLAMMATION WAS IMPROVED AND NO FURTHER INJECTIONS OR ASPIRATIONS WERE PERFORMED. ON THAT SAME DAY, THE PATIENT VISITED HER PRIMARY PHYSICIAN, WHO OBTAINED BLOOD WORK FOR UNSPECIFIED TESTING, BUT THE RESULTS WERE UNKNOWN. ON (B)(6) 2011, WHILE THE INJECTING PHYSICIAN WAS PROVIDING THE REPORT VIA TELEPHONE, THE PHYSICIAN INDICATED THAT HE HAD JUST BEEN INFORMED THAT THE PATIENT HAD PRESENTED TO THE HOSPITAL. DETAILS OF THE POSSIBLE HOSPITALIZATION WERE UNKNOWN AND HE HAD NO FURTHER INFORMATION TO PROVIDE. AS ON (B)(6) 2011, STATUS OF THE EVENTS WAS UNKNOWN. THE PHYSICIAN STATED THE TREATMENT WITH PERLANE CAUSED THE REPORTED EVENTS. THE PHYSICIAN ASSESSED THE SEVERITY OF THE EVENTS AS SEVERE. IT WAS REPORTED THAT THE PATIENT RECEIVED PERLANE. THE LOT NUMBER REPORTED IS VALID FOR PERLANE-L (CROSS-LINKED HYALURONIC ACID DERMAL FILLER WITH 0.3% LIDOCAINE). THE LOT NUMBER AND EXPIRATION DATE WERE 10928 AND JUNE 2012, RESPECTIVELY.