Description of Event or Problem · 1
ON (B)(6) 2012, A SPONTANEOUS REPORT BY A REGISTERED NURSE (RN) WAS RECEIVED FROM A COMPANY REP REGARDING A PT WHO RECEIVED AN INJECTION OF RESTYLANE-L (CROSS-LINKED HYALURONIC ACID DERMAL FILLER WITH 0.3% LIDOCAINE). ON (B)(6) 2012, ADDITIONAL INFO WAS RECEIVED FROM THE INFECTIOUS DISEASE PHYSICIAN VIA FAX. BASED ON THE INFO RECEIVED, THE CASE WAS UPGRADED DUE TO UNEXPECTED SEVERITY. MEDICAL HISTORY, THE PT¿S SKIN TYPE, AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PT RECEIVED AN INJECTION OF RESTYLANE-L (VOLUME INJECTED AND SYRINGE SIZE NOT REPORTED) ON AN UNK DATE TO AN UNSPECIFIED SITE. PRE-PROCEDURE MEDICATIONS AND ADD¿L PROCEDURES PERFORMED AT THE TIME OF IMPLANTATION WERE NOT REPORTED. ON AN UNK DATE, AFTER THE IMPLANTATION, THE PT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT. THE LOT NUMBER AND EXPIRATION DATE FOR RESTYLANE-L WERE NOT REPORTED. ON (B)(6) 2012, ADD¿L INFO WAS RECEIVED FROM THE NURSE. THE NURSE FURTHER IDENTIFIED THE PT AS A (B)(6) FEMALE, BUT HAD NO FURTHER INFO TO PROVIDE. ON (B)(6) 2012, ADDITIONAL INFO WAS RECEIVED FROM THE PT. THE PT WAS FURTHER IDENTIFIED AS (B)(6). MEDICAL HISTORY INCLUDED AN INJECTION OF BOTOX (ONABOTULINUMTOXINA) ON AN UNK DATE (REPORTED AS ¿IN THE PAST¿) TO THE FOREHEAD WITHOUT PROBLEMS, AND WAS OTHERWISE REPORTED AS ¿NONE.¿ THE PT¿S SKIN TYPE WAS REPORTED AS ¿PALE.¿ CONCOMITANT MEDICATIONS INCLUDED CELEXA (CITALOPRAM HYDROBROMIDE) AND SPIRONOLACTONE. THE PT RECEIVED AN INJECTION OF RESTYLANE-L (VOLUME INJECTED UNK) FROM WHAT WAS THOUGHT TO BE A 1 ML SYRINGE ON AN UNSPECIFIED DATE IN 2012 (REPORTED AS ¿APPROXIMATELY (B)(6) AGO¿ FROM THE DATE OF THE REPORT) TO THE NASOLABIAL FOLDS AND LIPS VIA AN UNKNOWN INJECTION TECHNIQUE. PRE-PROCEDURE MEDICATIONS INCLUDED AN UNSPECIFIED TOPICAL NUMBING CREAM. NO ADD¿L PROCEDURES WERE PERFORMED AT THE TIME OF IMPLANTATION. ON AN UNSPECIFIED DATE IN 2012 (REPORTED AS ¿5 WEEKS POST INJECTION¿), THE PT DEVELOPED TENDERNESS AND TWO FACIAL ABSCESSES ON HER RIGHT NASOLABIAL FOLD. ON AN UNSPECIFIED DATE IN 2012, THE PT WENT TO AN URGENT CARE AND WAS PRESCRIBED AUGMENTIN (AMOXICILLIN AND CLAVULANATE) AND PREDNISONE ORALLY FOR ONE WEEK, AFTER WHICH HER SYMPTOMS ALMOST RESOLVED. AS SOON AS THE PREDNISONE WAS DONE, THE PT¿S SYMPTOMS CAME BACK WORSE: THE TWO ABSCESSES CAME BACK AND ANOTHER ONE APPEARED ON THE RIGHT SIDE. ON (B)(6) 2012, THE PT WENT TO THE PLASTIC SURGEON, WHO ASPIRATED ABOUT 2ML OF BLOOD OUT OF THE AREAS (THERE WAS NO PUS) AND AN UNSPECIFIED ¿WOUND CULTURE¿ OF THE AREA WAS PERFORMED. THE PT WAS STARTED ON BACTRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) ORALLY. ON (B)(6) 2012, THE PT DEVELOPED SWELLING FROM THE EYE AREA DOWN TO THE CHIN ON HER RIGHT SIDE; SUBSEQUENTLY, SHE WENT TO THE EMERGENCY ROOM. NO TREATMENT OR DIAGNOSIS WAS PROVIDED; NOTHING WAS DONE. ON (B)(6) 2012, THE CULTURE CAME BACK NEGATIVE AND THE PT WENT BACK TO THE INJECTING NURSE. THE PT WAS STARTED ON AUGMENTIN 500 MG TWICE DAILY, BACTRIM 800 MG TWICE DAILY FOR 10 DAYS, AND A PREDNISONE TAPER. THE PT WAS REFERRED TO AN INFECTION CONTROL HEALTHCARE PROVIDER. AS OF (B)(6) 2012, THE PT¿S SWELLING WAS JUST AROUND THE ABSCESS AREAS AND WAS MUCH IMPROVED. THE PT PLANNED TO HAVE A FACIAL ULTRASOUND THAT DAY. THE LOT NUMBER AND EXPIRATION DATE FOR RESTYLANE-L WERE UNKNOWN. ON (B)(6) 2012, ADD¿L INFO WAS RECEIVED FROM THE INJECTING NURSE AND AN EVALUATING NURSE FROM THE INJECTING CLINIC. BASED ON THE INFO RECEIVED, THE FOLLOWING EVENTS WERE ADDED: IMPLANT SITE NODULE, PURULENT DISCHARGE, IMPLANT SITE ERYTHEMA, IMPLANT SITE INFLAMMATION, AND IMPLANT SITE WARMTH. THE INJECTING NURSE CONFIRMED THAT THE PT RECEIVED AN INJECTION OF RESTYLANE-L FROM A 1 ML SYRINGE ON (B)(6) 2012 TO THE NASOLABIAL FOLDS (0.3 CC TO THE RIGHT NASOLABIAL FOLD AND 0.2 CC TO THE LEFT NASOLABIAL FOLD) AND THE LIPS (VOLUME INJECTED NOT REPORTED) VIA LINEAR THREADING INJECTION TECHNIQUE. PRE-PROCEDURE MEDICATIONS INCLUDED TOPICAL LIDOCAINE 25% CREAM. THE EVALUATING NURSE REPORTED THAT SHE EVALUATED THE PT ON (B)(6) 2012. AT THE TIME OF THE EVAL, THE PT¿S RIGHT NASOLABIAL FOLD AREA WAS NOT RED OR INFLAMED, BUT NODULES COULD BE PALPATED. THE PT WAS REFERRED TO A PLASTIC SURGEON FOR FURTHER EVAL. THE EVALUATING NURSE CONFIRMED THAT THE PLASTIC SURGEON HAD ASPIRATED PUS AND BLOOD FROM NODULES IN THE RIGHT NASOLABIAL FOLD, THE PT WAS PLACED ON BACTRIM, AND CULTURES WERE NEGATIVE. ON (B)(6) 2012, THE PT SENT PICTURES TO THE EVALUATING NURSE. THE PICTURES SHOWED INCREASED RIGHT NASOLABIAL FOLD SWELLING, REDNESS, AND INFLAMMATION AND THE NODULES WERE REPORTED TO BE WARM AND TENDER. ON (B)(6) 2012, THE PT WAS ASPIRATED FOR A SECOND CULTURE (RESULTS UNK) BY AN UNSPECIFIED HEALTH CARE PROVIDER. AS OF (B)(6) 2012, THE NURSE HAD NOT OBSERVED THE PT IN ANY MANNER SINCE (B)(6) 2012 AND WAS UNABLE TO CONFIRM THE DIAGNOSIS OF ABSCESS. THE STATUS OF THE TENDERNESS TO THE RIGHT NASOLABIAL FOLD WAS UNK AND THE SWELLING FROM THE EYE AREA DOWN TO THE CHIN ON THE PT¿S RIGHT SIDE HAD NEVER BEEN OBSERVED BY THE RN. NO TREATMENT HAD BEEN PROVIDED BY THE INJECTING CLINIC AND NO FOLLOW-UP WITH THE INJECTING CLINIC WAS PLANNED. THE PT WAS REFERRED TO AN INFECTIOUS DISEASE PHYSICIAN FOR EVAL, BUT NO DETAILS OF AN EVAL WERE KNOWN. THE EVALUATING NURSE¿S OPINION OF CAUSALITY WAS THAT THE TREATMENT DID NOT CAUSE THE REPORTED EVENTS. IT WAS FURTHER REPORTED THAT THE NURSE ¿DID NOT THINK THE INJECTIONS HAD ANYTHING TO DO WITH IT; IT WAS LIKELY SOMETHING FROM THE HOSPITAL WHERE THE PT WORKED THAT STIMULATED SOMETHING IN THE PRODUCT TO CAUSE THE REACTION. IT WAS NOT DUE TO THE INJECTIONS, AS IT OCCURRED 5 WEEKS AFTER THE INJECTION; IT WAS LIKELY THAT SHE PICKED UP SOMETHING FROM THE HOSPITAL WHERE SHE WORKED.¿ THE EVALUATING NURSE ASSESSED THE SEVERITY OF THE REPORTED EVENTS AS ¿MODERATE.¿ THE LOT NUMBER AND EXPIRATION DATE FOR RESTYLANE-L WERE UNK, AS THE PACKAGING HAD BEEN DISCARDED. ON (B)(6) 2012, ADD¿L INFO PROVIDED BY THE INFECTIOUS DISEASE PHYSICIAN WAS RECEIVED VIA FAX. BASED ON THE INFO RECEIVED, THE EVENT OF INJECTION SITE CELLULITIS WAS ADDED. THE EVENTS OF INJECTION SITE PAIN, IMPLANT SITE NODULE, IMPLANT SITE SWELLING, IMPLANT SITE ERYTHEMA, IMPLANT SITE INFLAMMATION, AND IMPLANT SITE WARMTH WERE SUBSUMED UNDER INJECTION SITE CELLULITIS. THE EVENT OF PURULENT DISCHARGE WAS SUBSUMED UNDER IMPLANT SITE ABSCESS. THE PT WAS FURTHER IDENTIFIED AS A (B)(6). ON (B)(6) 2012, THE PT PRESENTED TO THE INFECTIOUS DISEASES PHYSICIAN VIA REFERRAL FROM A PHYSICIAN AT THE INJECTING FACILITY AND A PLASTIC SURGEON FOR EVAL OF PERIORAL CELLULITIS. REVIEW OF PT MEDICATIONS DETERMINED THE FOLLOWING: AUGMENTIN 500/125 MG AT 1 TABLET TWICE DAILY, BACTRIM DS 800/160 MG AT 1 TABLET TWICE DAILY, PREDNISONE 10 MG TAPER ONCE DAILY (ALSO REPORTED AS ¿STOP DATE (B)(6) 2012¿). THE PT¿S FAMILY MEDICAL HISTORY INCLUDED ARTHRITIS. THE PT¿S SOCIAL HISTORY INCLUDED NO TOBACCO USE, ¿NO SNIFFING, AND ALCOHOL USE.¿ MEDICAL HISTORY INCLUDED NO KNOWN DRUG ALLERGIES (NKDA). GENERAL REVIEW OF SYMPTOMS BY THE PT WAS REPORTED AS SKIN: DENIED RASH; LYMPH: DENIED LYMPH GLAND SWELLING; HEAD, EYES, EARS, NOSE, AND THROAT (HEENT): DENIED AUDIO-VISUAL SYMPTOMS, SINUS CONGESTION, ORAL LESIONS, AND THROAT DISCOMFORT; RESPIRATORY: DENIED COUGH, SPUTUM, SHORTNESS OF BREATH AND WHEEZING; CARDIOVASCULAR: DENIED CHEST PAIN, PALPITATIONS, PAROXYSMAL NOCTURNAL DYSPNEA (PND), AND ORTHOPNEA; GASTROINTESTINAL: DENIED ABDOMINAL PAIN, NAUSEA, VOMITING, AND DIARRHEA; ENDOCRINE: DENIED HYPERGLYCEMIC AND HYPOGLYCEMIC EPISODES; MUSCULOSKELETAL: DENIED MYALGIAS, ARTHRALGIAS, AND ARTHRITIS; AND NEUROLOGIC: DENIED HEADACHE, SEIZURES, RADICULAR PAIN, PARESTHESIAS, AND WEAKNESS. THE PT¿S HISTORY OF PRESENT ILLNESS (HPI) WAS REPORTED AS FOLLOWS: A (B)(6) WHO UNDERWENT NASOLABIAL FOLD INJECTION WITH ¿RESTYLANE¿ (PREVIOUSLY REPORTED AND CONFIRMED AS RESTYLANE-L BY THE INJECTING FACILITY). THE PT ¿DID WELL¿ UNTIL AN UNSPECIFIED DATE IN (B)(6) 2012 (REPORTED AS ¿UNTIL APPROX (B)(6) AGO¿ FROM THE DATE OF THE REPORT), WHEN SHE NOTICED ACUTE SWELLING AND TENDERNESS ON THE RIGHT SIDE OF HER FACE. THE PT DENIED ANY FEVER, CHILLS, SWEATS, OR ANY SPECIFIC TRAUMA. THE LEFT SIDE OF HER FACE AND LIP HAD BEEN UNAFFECTED. INITIAL TREATMENT WAS REPORTED TO HAVE INCLUDED PREDNISONE AND AUGMENTIN. THE PT NOTICED SIGNIFICANT IMPROVEMENT OVER THE NEXT WEEK, BUT IT ¿FLARED BACK UP¿ AS SHE TAPERED HER STEROIDS, ON (B)(6) 2012, THE PT WAS EVALUATED BY THE PLASTIC SURGEON AND ASPIRATION OF A FLUID POCKET REVEALED NO ORGANISMS WITH MANY RED BLOOD CELLS (RBC) AND FEW POLYMORPHONUCLEAR LEUKOCYTES (PMN); PRELIMINARY CULTURES SHOWED NO GROWTH. THE PT¿S VITAL SIGNS WERE AS FOLLOWS: BLOOD PRESSURE (BP) 130/70 MM HG, TEMPERATURE 98.7 F, AND HEART RATE (HR) 84 PER MINUTE. THE PT¿S WEIGHT WAS (B)(6), HEIGHT (B)(6), AND BODY MASS INDEX (BMI) (B)(6). GENERAL EXAMINATION WAS REPORTED AS GENERAL APPEARANCE: IN NO ACUTE DISTRESS, WELL DEVELOPED, AND WELL NOURISHED; HEAD: NORMOCEPHALIC AND ATRAUMATIC; EYES: PUPILS EQUAL, ROUND, REACTIVE TO LIGHT AND ACCOMMODATION; EARS: NORMAL; NOSE: NARES PATENT, NO LESIONS, SEPTUM INTACT; ORAL CAVITY: MUCOSA MOIST; THROAT: CLEAR; NECK/THYROID: NECK SUPPLE, FULL RANGE OF MOTION, NO CERVICAL LYMPHADENOPATHY; LYMPH NODES: NO CERVICAL ADENOPATHY; SKIN: RIGHT FACIAL SWELLING WITH AN INDURATED, ERYTHEMATOUS, AND TENDER REGION AT THE UPPER PORTION OF HER RIGHT NASOLABIAL FOLD. DIMENSIONS WERE APPROXIMATELY 2 CM IN LENGTH BY 1 CM IN WIDTH AND DID NOT INVOLVE THE NARES. ORAL EXAMINATION WAS NORMAL. THE INFECTIOUS DISEASE PHYSICIAN¿S PRIMARY ASSESSMENT WAS CELLULITIS AND ABSCESS OF THE FACE. THE PT HAD POST ¿RESTYLANE¿ INJECTION INFLAMMATORY REACTION. THE ASPIRATION REVEALED BLOOD. THIS WAS AN UNUSUAL PRESENTATION OF A HEMATOMA, SPECIFICALLY THAT LATE IN ONSET. THE INFECTIOUS DISEASES PHYSICIAN SUSPECTED A POSSIBLE ABSCESS, WHICH COULD HAVE BEEN A STERILE ABSCESS RELATED TO THE CHEMICAL INJECTION. THE PREVIOUSLY PRESCRIBED AUGMENTIN AT 500/125 MG ORALLY TWICE DAILY WAS STOPPED AND TREATMENT INCLUDED: BACTRIM DS 800/160 MG AT 1 TABLET ORALLY TWICE DAILY FOR 10 DAYS AND AUGMENTIN 875/125 MG AT TABLET ORALLY TWICE DAILY FOR 10 DAYS. A PREDNISONE TAPER WAS INITIATED AT 20 MG TO BE TAKEN WITH FOOD OR MILK ORALLY FOR 2 DAYS, 10 MG TWICE DAILY FOR 3 DAYS, AND 10 MG EACH DAY UNTIL THE PT RETURNED IN 1 WEEK. THE PT WAS INSTRUCTED TO HOT PACK THE FACE 3 TIMES PER DAY AND TO CALL IF THERE WAS ANY WORSENING OF HER SWELLING OR INTOLERANCE OF HER TREATMENTS. AN ULTRASOUND OF THE RIGHT CHEEK WAS TO BE OBTAINED ON AN UNSPECIFIED DATE. ON (B)(6) 2012, AN ULTRASOUND (US) GUIDED ASPIRATION OF THE RIGHT CHEEK FLUID COLLECTION WAS PERFORMED FOR THE FACIAL ABSCESS BY THE INFECTIOUS DISEASES PHYSICIAN. THE PT WAS PREPPED AND DRAPED. LOCAL ANESTHESIA WAS OBTAINED WITH 1% XYLOCAINE (LIDOCAINE) MIXED WITH BICARBONATE. ULTRASOUND WAS USED TO GUIDE A 21 GAUGE NEEDLE, WHICH WAS ADVANCED INTO AN ELONGATED HYPOECHOIC COLLECTION IN THE SUBCUTANEOUS TISSUE OF THE RIGHT CHEEK, WHICH CORRESPONDED TO THE AREA OF CLINICAL ABNORMALITY. THE COLLECTION MEASURED 2.1 X 0.7X 1.4 CM ON PRE-PROCEDURAL SONOGRAPHY. THE TIP OF THE NEEDLE WAS CENTERED WITHIN THE PROCESS AND AN ASPIRATION OF A TINY AMOUNT OF PURULENT APPEARING MATERIAL WAS ASPIRATED. THE FLUID WAS DILUTED IN A SMALL AMOUNT OF NORMAL SALINE AND WAS SENT TO THE LABORATORY FOR AEROBIC AND ANAEROBIC CULTURE. NO IMMEDIATE COMPLICATIONS WERE ENCOUNTERED AND THE PT WAS DISMISSED. THE IMPRESSION NOTED WAS AN APPARENTLY TECHNICALLY SUCCESSFUL ULTRASOUND-GUIDED ASPIRATION OF A TINY AMOUNT OF PURULENT MATERIAL FROM A RIGHT FACIAL ABSCESS AS DESCRIBED. ON (B)(6) 2012, THE FINDINGS WERE DISCUSSED WITH THE PT; SHE COULD FOLLOW UP WITH THE PLASTIC SURGEON. ON (B)(6) 2012, A CERTIFICATION BY THE HEALTHCARE PROVIDER FOR THE FAMILY AND MEDICAL LEAVE ACT WAS COMPLETED BY THE INFECTIOUS DISEASES PHYSICIAN WHO INDICATED THAT THE APPROXIMATE DATE THE CONDITION COMMENCED WAS (B)(6) 2012. NO OVERNIGHT ADMISSION TO A MEDICAL CARE FACILITY WAS INDICATED. PREGNANCY WAS NOT INDICATED AND THE PT WAS NOT DEEMED UNABLE TO PERFORM ANY OF HER JOB FUNCTIONS DUE TO HER CONDITION. THE PT WAS NOTED TO REQUIRE LEAVE OF WORK ON (B)(6) 2012 (FOR APPOINTMENT AND OUTPATIENT SURGERY), AND (B)(6) 2012. THE INFECTIOUS DISEASES PHYSICIAN¿S OPINION OF CAUSALITY WAS THAT THE PT HAD A POST RESTYLANE INJECTION INFLAMMATORY REACTION. AN ABSCESS WAS SUSPECTED, WHICH COULD HAVE BEEN STERILE ABSCESS RELATED TO THE ¿CHEMICAL¿ INJECTION. THE INFECTIOUS DISEASES PHYSICIAN DID NOT OFFER A STATEMENT OF SEVERITY. ADD¿L INFO HAS BEEN REQUESTED.