Description of Event or Problem · 1
ON (B)(4) 2011, A SPONTANEOUS REPORT WAS RECEIVED REGARDING A (B)(6) FEMALE WHO RECEIVED AN INJECTION OF PERLANE-L (CROSS-LINKED HYALURONIC ACID DERMAL FILLER WITH 0.3% LIDOCAINE). ON 28-JUL-2011, ADD'L INFO WAS RECEIVED FROM A PHYSICIAN. BASED ON THE INFO RECEIVED, THE CASE WAS DETERMINED TO BE REPORTABLE DUE TO THE CONFIRMATION OF UNLABELED EVENTS. MEDICAL HISTORY INCLUDED NO PREVIOUS INJECTION OF DERMAL FILLERS; NO ALLERGIES AND COLD SORE VIRUS WITH NO SYMPTOMS PRESENT AT THE TIME OF INFECTION. THE PT'S SKIN TYPE WAS (B)(6). THE PT WAS NOT TAKING ANY CONCOMITANT MEDICATIONS. THE PT RECEIVED AN INJECTION OF PERLANE-L (SYRINGE SIZE UNK AND AMOUNT INJECTED NOT REPORTED) ON (B)(6) 2011 TO THE NASOLABIAL FOLDS, CHIN, MARIONETTE LINES AND UNDER THE EYES NEAR THE NOSE. NO PRE-PROCEDURE MEDICATION WAS USED AND NO ADD'L PROCEDURES WERE PERFORMED AT THE TIME OF IMPLANTATION. ON (B)(6) 2011, AFTER THE IMPLANTATION, THE PT NOTICED SMALL LUMPS IN THE LEFT CORNER OF HER MOUTH. ON (B)(6) 2011, THE PT VISITED THE INJECTOR FOR A F/U APPOINTMENT AND WAS ASYMPTOMATIC. ON (B)(6) 2011, THE PT NOTICED AN INDENTATION AND A DRY PATCH ON HER NOSE. ON (B)(6) 2011, THE PT WAS EVALUATED BY A STAFF MEMBER (TITLE UNK) AT THE INJECTING CLINIC. THE STAFF MEMBER DID NOT NOTE AN INDENTATION UPON EXAMINATION. TREATMENT FOR THE DRY PATCH INCLUDED AN UNSPECIFIED CREAM PRESCRIBED BY THE STAFF MEMBER. BY (B)(6) 2011, THE DRY PATCH RESOLVED. ON (B)(6) 2011, THE PT'S FACE BECAME SENSITIVE TO THE TOUCH AND EXPRESSED HER CONCERNS TO THE INJECTING CLINIC AND WAS TOLD THAT MAY BE SHE WAS DEVELOPING COLD SORES AND WAS INSTRUCTED TO START TAKING VALACYCLOVIR 500 MG ONE TABLET TWICE DAILY. ON (B)(6) 2011, THE PT FOLLOWED UP WITH A PHYSICIAN AT THE INJECTING CLINIC WHO "MASSAGED DOWN THE BUMPS" AT THE LEFT CORNER OF HER MOUTH. ON (B)(6) 2011, THE PT BEGAN TO EXPERIENCE WAVES OF BURNING AND PRICKLING ON HER FACE, NUMBNESS ON THE TOP OF HER HEAD, INCREASED HEART RATE AND HEART PALPITATION. ON (B)(6) 2011, THE PT BEGAN TAKING VALACYCLOVIR. ON (B)(6) 2011, THE PT EXPERIENCED DRY MOUTH AND PROGRESSION OF THE PREVIOUS SYMPTOMS AND ATTEMPTED TO CONTACT THE PHYSICIAN AT THE INJECTING CLINIC, BUT HAD TO LEAVE A VOICEMAIL MESSAGE. LATER IN THE DAY ON (B)(6) 2011, THE PT RECEIVED A VOICE MESSAGE FROM THE PHYSICIAN RECOMMENDING THAT SHE SEEK TREATMENT FROM HER PRIMARY CARE PHYSICIAN OR A NEUROLOGIST. ON (B)(6) 2011, THE PT EXPERIENCED BURNING DOWN HER ARMS AND BACK AND PROGRESSION OF THE PREVIOUS SYMPTOMS. BY (B)(6) 2011, THE BUMPS HAD DISSIPATED, BUT THE OTHER SYMPTOMS HAD PROGRESSED AND THE PT PRESENTED TO THE EMERGENCY ROOM (ER) AT 2:00 AM. THE PT'S HEART RATE TAKEN BY A HEALTHCARE PROVIDER WAS 120 AND HER BLOOD PRESSURE, ALSO TAKEN BY A HEALTHCARE PROVIDER, WAS 170S/120S. TREATMENT INCLUDED BENADRYL (DIPHENHYDRAMINE) (DOSE UNK), UNSPECIFIED INTRAVENOUS (IV) FLUIDS, AN UNSPECIFIED MEDICATION FOR UPSET STOMACH AND AN UNSPECIFIED MEDICATIONS FOR HIGH BLOOD PRESSURE. BLOOD WAS TAKEN FOR UNSPECIFIED TESTS, INCLUDING BLOOD FOR AN UNSPECIFIED THYROID TEST AND "EVERYTHING WAS OK." THE PT WAS INSTRUCTED TO F/U WITH HER PHYSICIAN AND WAS RELEASED FROM THE EMERGENCY ROOM LATER IN THE DAY ON (B)(6) 2011. THE PT NOTICED AFTER DISCHARGE FROM THE EMERGENCY ROOM THAT THE CAPILLARIES WERE ENLARGED AROUND HER NOSE AN ON HER FACE AND SHE HAD BLUISH SKIN AND RED LINES AROUND THE INJECTION SITES. THE PT HAD AN APPOINTMENT SCHEDULED WITH A NEUROLOGIST ON (B)(6) 2011. ON (B)(6) 2011, ADD'L INFO WAS RECEIVED FROM THE PT. ON AN UNSPECIFIED DATE IN 2011, THE PT VISITED A DERMATOLOGIST WHO TOLD THE PT THAT "PERLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER) WAS STARTING TO COME OUT," WHICH COULD NOT BE FURTHER DESCRIBED BY THE PT. NO TESTS, DIAGNOSIS OR TREATMENT WERE PROVIDED BY THE DERMATOLOGIST. ON (B)(6) 2011, THE PT WAS EVALUATED BY HER PRIMARY CARE PHYSICIAN FOR HER HIGH BLOOD PRESSURE WHICH WAS 150/100 THAT DAY. THE PT WAS TOLD THAT SHE WAS PROBABLY ALLERGIC TO PERLANE-L AND HER NERVES WERE IRRITATED. THE PT WAS PRESCRIBED AN UNSPECIFIED PAIN MEDICATION FOR HER FACIAL DISCOMFORT AND BURNING, BUT STATED THAT SHE WOULD NOT TAKE THE MEDICATION, AS HER FACE WASN'T REALLY PAINFUL. ON (B)(6) 2011, THE PT WAS EVALUATED BY A NEUROLOGIST WHO STATED THAT THE PERLANE-L WAS PUT NEAR THE NERVES IN HER FACE AND WAS DIAGNOSED WITH NEURALGIA. NO TREATMENTS, EXAMS/TESTS WERE PERFORMED AND THE PT WAS TOLD TO "WAIT IT OUT." AS OF (B)(6) 2011, ALL OF THE EVENTS WERE ONGOING. THE PT FURTHER STATED THAT SHE NEVER HAD AN UPSET STOMACH, SHE DID NOT DEVELOP ANY COLD SORES AND THE RED LINES AT AND AROUND THE INJECTIONS SITES WERE EXPLANATION OF THE ENLARGED CAPILLARIES. THE PT ADDED THAT SHE HAD A FEW WHITISH SPOTS NEAR HER NASOLABIAL FOLDS AND THAT ALL OF THE SYMPTOMS GOING ON HAD MADE HER DEPRESSED. THE LOT NUMBER AND EXPIRATION DATE WERE REPORTED AS UNK. THE PT REFUSED TO PROVIDE HEALTHCARE PROVIDER CONTACT INFO. THE PT INITIALLY REFUSED AND STATED THAT SHE DID NOT HAVE A HEALTHCARE PROVIDER. THE PT LATER STATED THAT SHE COULD NOT REMEMBER THEIR NAMES OR WHERE THEY WORKED AND WOULD CALL BACK TO PROVIDE THIS INFO. ON 28-JUL-2011, ADD'L INFO WAS RECEIVED FROM A PHYSICIAN VIA FAX. THE PT HAD 3 SYRINGES OF PERLANE (SYRINGE SIZE NOT REPORTED) INJECTED ON (B)(6) 2011. ON (B)(6) 2011, THE PT PRESENTED TO THE PHYSICIAN'S OFFICE COMPLAINING OF BURNING SENSATION OF HER FACE ACCOMPANIED BY FACIAL SWELLING, REDNESS AND PALPITATIONS. THE PT VISITED THE EMERGENCY ROOM TWICE AND HIGH BLOOD PRESSURE WAS RECORDED (DIASTOLIC 112). THE PT SAW A NEUROLOGIST WHO CLAIMED HER SYMPTOMS COULD BE TRACED TO AN ALLERGY OR IRRITATION FROM SOME COMPONENT IN THE FILLERS. THE PHYSICIAN DID NOT REPORT THE CAUSALITY OR ASSESS THE SEVERITY OF THE REPORTED EVENTS. IT WAS REPORTED BY THE PHYSICIAN THAT THE PT RECEIVED PERLANE. THE LOT NUMBERS REPORTED ARE VALID FOR PERLANE-L. THE LOT NUMBER FOR ONE SYRINGE OF PERLANE-L WAS 10882 AND THE LOT NUMBER FOR THE OTHER TWO SYRINGES OF PERLANE-L WAS 10692. THE EXPIRATION DATES FOR THE 3 SYRINGES OF PERLANE-L WERE NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED FROM THE PHYSICIAN.