Description of Event or Problem · 1
ON (B)(6) 2011, A SPONTANEOUS REPORT BY A CERTIFIED PHYSICIAN ASSISTANT WAS RECEIVED FROM A COMPANY REP REGARDING A (B)(6) FEMALE WHO RECEIVED AN INJECTION OF RESTYLANE-L ((B)(4)). MEDICAL HISTORY INCLUDED PRIOR INJECTIONS OF RESTYLANE ((B)(4)) AND BOTOX (ONABOTULINUMTOXINA) ON AN UNSPECIFIED DATE IN 2010 (REPORTED AS, "ABOUT (B)(6) AGO," FROM THE DATE OF THE REPORT); HIGH BLOOD PRESSURE; AND A "LOW PAIN THRESHOLD." THE PT HAD NO OTHER MEDICAL CONDITIONS; NO HISTORY OF SEIZURES; NO HISTORY OF MEMORY LOSS OR CONFUSION; AND NO ALLERGIES. THE PT'S SKIN TYPE WAS FITZPATRICK II. CONCOMITANT MEDICATIONS INCLUDED DIOVAN (VALSARTAN) 80 MG DAILY. THE PT RECEIVED A 1.0 ML INJECTION OF RESTYLANE-L ON (B)(6) 2011, DISTRIBUTED EVENLY TO THE GLABELLA, BILATERAL TEAR TROUGHS AND BILATERAL NASOLABIAL FOLDS. PRE-PROCEDURE MEDICATIONS INCLUDED APPLICATION OF THE TOPICAL NUMBING CREAM "LIPODERM" TO THE RESTYLANE-L INJECTION SITES. ADD'L PROCEDURES PERFORMED AT THE TIME OF IMPLANTATION INCLUDED DYSPORT (ABOBOTULINUMTOXINA) TO THE FOREHEAD, GLABELLA, CROWS FEET AND JAW LINE. THE PT'S FIRST TREATMENTS WITH RESTYLANE-L AND DYSPORT WERE ON (B)(6) 2011. ON (B)(6) 2011, THE CERTIFIED PHYSICIAN ASSISTANT, WHO IDENTIFIED HERSELF AS THE INJECTOR AND THE PT'S DAUGHTER-IN-LAW, FIRST INJECTED THE PT WITH DYSPORT. AFTER THE DYSPORT TREATMENT, THE TOPICAL NUMBING CREAM "LIPODERM" WAS APPLIED TO THE RESTYLANE-L INJECTION SITES. THE INJECTOR THEN STEPPED OUT OF THE TREATMENT ROOM FOR APPROX 30 MINUTES TO SEE ANOTHER PT. THE INJECTOR THEN RETURNED TO THE PT'S ROOM AND PERFORMED THE RESTYLANE-L INJECTION. THE PT EXPERIENCED PAIN DURING THE RESTYLANE-L INJECTION. WITHIN MINUTES OF THE RESTYLANE-L INJECTION, THE PT DEVELOPED BRUISING TO THE RIGHT ORBITAL RIM, LATERALLY. THE PT WAS THEN PLACED UNDER "RED LIGHTS" FOR 20 MINUTES, TO PROMOTE HEALING AND REDUCE BRUISING. TEN MINUTES AFTER THE RED LIGHT TREATMENT WAS COMPLETED, THE PT INFORMED THE INJECTOR THAT SHE DIDN'T REMEMBER THE PROCEDURE OR WHAT WAS DONE. THE INJECTOR NOTED THAT THE PT WAS NO EXHIBITING ANY OTHER SYMPTOMS AND THE INJECTOR THOUGHT THAT THE PT WAS "JUST KIDDING AROUND." THE PT CONTINUED TO REPORT THAT SHE COULDN'T REMEMBER THE PROCEDURE. AT THIS POINT, THE INJECTOR THOUGHT PERHAPS THIS WAS BECAUSE THE PT MAY HAVE BEEN "OVERWHELMED" FROM THE PAIN SHE HAD EXPERIENCED DURING THE RESTYLANE-L INJECTION, DUE TO THE PT'S LOW PAIN THRESHOLD. THE PT KNEW WHERE SHE WAS AND RECOGNIZED THE PEOPLE AROUND HER, SO THE INJECTOR WAS NOT CONCERNED. THE PT STAYED IN THE CLINIC FOR APPROX 40 MINUTES, AS THE INJECTOR DID NOT WANT THE PT TO DRIVE HOME BY HERSELF. THE PT CONTINUED TO REPORT THAT SHE DIDN'T REMEMBER THE PROCEDURE. THE INJECTOR DROVE THE PT HOME. DURING THE DRIVE TO THE PT'S HOME, THE PT BEGAN TO EXPERIENCE ANTEROGRADE AMNESIA AND DIDN'T REMEMBER WHAT THEIR CONVERSATION HAD CONSISTED OF 10 MINUTES PRIOR. THE PT WAS ORIENTED TO PERSON AND PLACE, BUT NOT TIME. THE PT THEN BEGAN TO EXPERIENCE MID-STERNAL CHEST TIGHTNESS AND THE INJECTOR CALLED 911. THE AMBULANCE ARRIVED AND THE PT'S BLOOD PRESSURE (BP) WAS 180/60. THE PT WAS TREATED WITH ASPIRIN AND TRANSPORTED TO AN EMERGENCY ROOM (ER). WHILE AT THE ER, "STROKE AND CARDIAC WORK-UPS" WERE PERFORMED, WHICH INCLUDED UNSPECIFIED BLOOD WORK AND A COMPUTERIZED TOMOGRAPHY (CT) AND MAGNETIC RESONANCE IMAGING (MRI) OF THE HEAD. THE RESULTS OF THE BLOOD WORK, CT AND MRI SCANS WERE NEGATIVE. THE ER STAFF WAS UNCERTAIN AS TO THE CAUSE OF THE PT'S SYMPTOMS AND A FORMAL DIAGNOSIS WAS NOT ESTABLISHED. IT WAS SPECULATED THAT THE PT MAY HAVE POSSIBLY HAD A SEIZURE FROM THE LIDOCAINE IN THE RESTYLANE-L. THE PT HAD NO OBSERVABLE SEIZURE ACTIVITY AND NO TREATMENT WAS PROVIDED. THE PT WAS ADMITTED TO THE HOSPITAL OVERNIGHT FOR OBSERVATION. ON (B)(6) 2011, AN ELECTROENCEPHALOGRAM (EEG) WAS PERFORMED, WHICH WAS NEGATIVE. NO TREATMENT WAS PROVIDED DURING THE HOSPITALIZATION. THE PT'S MEMORY LOSS AND CONFUSION LASTED APPROX 12 HOURS. DURING THE HOSPITALIZATION, THE PT'S CHEST TIGHTNESS RESOLVED. ON (B)(6) 2011, AT APPROX 4:00 PM, THE PT WAS DISCHARGED FROM THE HOSPITAL. UPON DISCHARGE, THE PT WAS INSTRUCTED TO INCREASE HER DIOVAN DOSAGE FROM 80 MG TO 180 MG DAILY, AS HER BP WAS ELEVATED. THE INJECTOR DID NOT KNOW WHAT THE SPECIFIC RESULTS OF ANY OF THE BLOOD PRESSURE MEASUREMENTS TAKEN DURING THE PT'S HOSPITALIZATION WERE. AT THE TIME OF DISCHARGE, THE PT WAS NOT INSTRUCTED TO F/U WITH A PHYSICIAN AND NO F/U APPOINTMENTS WERE SCHEDULED WITH THE INJECTOR. ON (B)(6) 2011, SHORTLY AFTER THE PT WAS DISCHARGED FROM THE HOSPITAL, SHE DEVELOPED A MINOR HEADACHE, WHICH THE INJECTOR DID NOT FEEL WAS SIGNIFICANT. ON (B)(6) 2011, WHEN THE INJECTOR SPOKE WITH THE PT, THE PT WAS STILL EXPERIENCING A MILD HEADACHE AND HAD NOT HAD ANY FURTHER MEMORY PROBLEMS. ON (B)(6) 2011, THE INJECTOR REPORTED THE PT FOLLOWED UP WITH HER PRIMARY PHYSICIAN REGARDING HER ELEVATED BP. THE PT DID NOT DISCUSS HER HEADACHE WITH THE PHYSICIAN. THE PHYSICIAN PRESCRIBED NORVASC (AMLODIPINE BESYLATE) IN ADDITION TO THE DIOVAN. AS OF (B)(6) 2011, THE PT'S BLOOD PRESSURE HAD RETURNED TO NORMAL LEVELS AND THE BRUISING TO THE RIGHT ORBITAL RIM HAD RESOLVED. THE PT CONTINUED TO HAVE A MILD HEADACHE, WHICH WAS LOCATED AT THE BACK OF THE HEAD AND RADIATED DOWN INTO THE BACK OF THE NECK. THE PT WAS SCHEDULED TO F/U WITH HER PRIMARY PHYSICIAN AGAIN ON AN UNSPECIFIED DATE SOMETIME DURING THE WEEK OF (B)(6) 2011. THE INJECTOR REPORTED THAT SHE WAS "NOT SURE IF THE PT'S EVENTS WERE RELATED TO THE LIDOCAINE IN THE RESTYLANE-L, ADDING THAT, SHE AGREED WITH THE ER STAFF THAT IT COULD NOT BE RULED OUT THAT THE LIDOCAINE IN THE RESTYLANE HAD CAUSED THE REPORTED EVENTS." THE INJECTOR ASSESSED THE SEVERITY OF THE REPORTED EVENTS AS SEVERE. THE LOT NUMBER AND EXP DATE WERE REPORTED AS UNK, AS THEY WERE NOT RECORDED AND THE SYRINGE HAD BEEN DISCARDED.