Description of Event or Problem · 1
ON (B)(6) 2011, A SPONTANEOUS REPORT BY A NURSE INJECTOR WAS RECEIVED FROM A COMPANY REPRESENTATIVE REGARDING A PATIENT (AGE AND SEX NOT REPORTED) WHO RECEIVED AN INJECTION OF PERLANE-L (CROSS-LINKED HYALURONIC ACID DERMAL FILLER WITH 0.3% LIDOCAINE). ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2011 FROM THE NURSE INJECTOR. BASED ON THE INFORMATION RECEIVED THE CASE WAS UPGRADED TO UNEXPECTED SEVERITY. THE COMPANY REPRESENTATIVE REPORTED THE PATIENT RECEIVED PERLANE-L ON (B)(6) 2011. ON AN UNSPECIFIED DATE IN (B)(6) 2011, AFTER THE IMPLANTATION, THE PATIENT DEVELOPED SOME SEVERE SWELLING. THE SWELLING WAS JUDGED TO BE EXCESSIVE BASED ON PHOTOS THAT THE PATIENT HAD SENT TO THE NURSE INJECTOR. THE PATIENT WAS TOLD TO GO TO THE EMERGENCY ROOM (ER) ON (B)(6) 2011 WHERE SHE WAS DIAGNOSED WITH AN INFECTION ON ONE SIDE OF THE FACE. TREATMENT FOR THE EVENT WAS UNKNOWN. THE PATIENT CONTACTED THE NURSE INJECTOR ON AN UNSPECIFIED DATE IN (B)(6) 2011. ON (B)(6) 2011, ADDITIONAL INFORMATION WAS RECEIVED FROM THE NURSE INJECTOR. THE PATIENT WAS IDENTIFIED AS A (B)(6) FEMALE (DATE OF BIRTH (B)(6)). THE NURSE INJECTOR CLARIFIED THAT THE PATIENT HAD NEVER PREVIOUSLY BEEN INJECTED WITH RESTYLANE-L OR PERLANE-L. MEDICAL HISTORY INCLUDED PREVIOUS INJECTION OF BOTOX (ONABOTULINUMTOXINA) AND JUVEDERM (CROSS-LINKED HYALURONIC ACID DERMAL FILLER) WITH NO REACTION; THE PATIENT HAD NO ALLERGIES OR MEDICAL CONDITIONS. THE PATIENT'S SKIN TYPE WAS FITZPATRICK II. THE PATIENT WAS NOT TAKING ANY CONCOMITANT MEDICATIONS. THE PATIENT RECEIVED A 1 ML INJECTION OF PERLANE-L ON (B)(6) 2011 TO THE RIGHT MARIONETTE LINE (0.2 ML), LEFT MARIONETTE LINE (0.3 ML), AND NASOLABIAL FOLDS (0.5 ML) USING A LINEAR THREADING TECHNIQUE. PRE-PROCEDURE MEDICATIONS INCLUDED TOPICAL LIDOCAINE. NO ADDITIONAL PROCEDURES WERE PERFORMED AT THE TIME OF IMPLANTATION. THE NURSE INJECTOR REPORTED THAT ON AN UNSPECIFIED DATE IN (B)(6) 2011, AFTER THE IMPLANTATION, THE PATIENT DEVELOPED SWELLING ON THE LEFT SIDE OF HER FACE, DESCRIBED AS "FROM THE EYE ALL THE WAY DOWN HER FACE". THE ONSET WAS GRADUAL. ON (B)(6) 2011, THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS TOLD THAT SHE HAD AN INFECTION ON HER FACE. THE PATIENT RECEIVED TWO INJECTIONS OF UNSPECIFIED ANTIBIOTICS AND AN UNSPECIFIED ORAL ANTIBIOTIC. IT WAS UNKNOWN IF ANY EXAMS OR TESTS WERE PERFORMED IN THE EMERGENCY ROOM. ON (B)(6) 2011, THE PATIENT NOTIFIED THE NURSE INJECTOR VIA PHONE AND INDICATED THAT THE EVENT WAS IMPROVING. ON (B)(6) 2011, THE NURSE INJECTOR SPOKE WITH THE PATIENT VIA PHONE AND WAS TOLD THAT THE EVENT WAS GETTING WORSE. AS OF (B)(6) 2011, THE PATIENT HAS NOT BEEN SEEN SINCE THE EMERGENCY ROOM VISIT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE NURSE INJECTOR WAS UNSURE IF THE TREATMENT CAUSED THE REPORTED EVENTS. THE NURSE INJECTOR ASSESSED THE SEVERITY OF THE EVENTS AS SEVERE. THE LOT NUMBER AND EXPIRATION DATE FOR PERLANE-L WERE REPORTED AS "1110 (THERE WAS NO "-1" AFTER THE EXP.)" AND MARCH 2013, RESPECTIVELY.