EVOLENCE COLLAGEN FILLER
Report
- Report Number
- 3005654090-2015-00001
- Event Type
- Injury
- Date Received
- February 24, 2015
- Report Date
- January 19, 2015
- Manufacturer
- COLBAR LIFESCIENCE, LTD
- Product Code
- LMH
- PMA / PMN Number
- 070013
- Removal / Correction Number
- NI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PATIENT
Narratives
THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.
THE DATE OF THIS SUBMISSION IS 24-FEB-2015. MANUFACTURING FOR THIS PRODUCT CEASED IN 2009 AND THE PMA WAS DELISTED PER FDA CORRESPONDENCE DATED DECEMBER 20, 2010 . THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.
THE DATE OF THIS SUBMISSION IS 01-JUN-2015. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.
THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.
THE DATE OF THIS SUBMISSION IS 30-MAR-2015. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.
THE DATE OF THIS SUBMISSION IS 22-APR-2015. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.
THIS SPONTANEOUS REPORT WAS RECEIVED ON 19-JAN-2015 FROM A (B)(6) YEAR-OLD CAUCASIAN FEMALE CONSUMER REPORTING ON SELF FROM THE UNITED STATES. MEDICAL HISTORY INCLUDED SINUS SURGERY, RHEUMATOID ARTHRITIS AND ALLERGIES TO DUST AND MOLD. SHE HAD NO KNOWN FOOD SENSITIVITIES. CONCOMITANT MEDICATIONS INCLUDED MULTIVITAMINS ONE PER DAY FOR UNSPECIFIED YEARS FOR GENERAL HEALTH AND ADVIL (IBUPROFEN) OR SOMETHING SIMILAR AS NEEDED AND PLAQUENIL (HYDROXYCHLOROQUINE) TWO PER DAY, BOTH TAKEN FOR UNSPECIFIED YEARS FOR RHEUMATOID ARTHRITIS. ON AN UNSPECIFIED DATE IN 2009, THE CONSUMER CONSULTED A FACIAL PLASTIC SURGEON. ON THE SAME NIGHT, THE PHYSICIAN INJECTED HER WITH EVOLENCE COLLAGEN FILLER (DOSE, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED) INTRADERMALLY, ONCE IN MULTIPLE LOCATIONS UNDER HER EYES FOR TREATMENT OF "HOLLOWS". DURING ADMINISTRATION, THE PHYSICIAN PRESSED DOWN AND RUBBED THE AREA. POST-INJECTION, SHE EXPERIENCED MINOR BRUISING AND SWELLING. SOON AFTER THE INJECTIONS, SHE BEGAN NOTICING LUMPS/BUMPS UNDER HER EYES. SHE WAS ALSO EXPERIENCING SIGNIFICANT SWELLING THAT LASTED FROM ONE TO THREE DAYS AND THE SWELLING RESOLVED; SHE WAS LEFT WITH BUMPS AND DROOPING, WRINKLED SKIN UNDER HER EYES. ON SEVERAL UNSPECIFIED DATES, SHE RETURNED TO THE PHYSICIAN WHO INJECTED HER WITH THE DEVICE. INITIALLY, SHE WAS ADVISED TO WAIT FOR THE SWELLING AND LUMPS TO GO DOWN AND THEN HER PHYSICIAN SUGGESTED PRESSING ON THE LUMPS. SHE WAS TREATED WITH A SERUM FROM THE PHYSICIAN'S PRODUCT LINE. THE PHYSICIAN ALSO ADVISED STEROID INJECTIONS INTO THE AFFECTED AREA IF SWOLLEN. AS RECENT AS (B)(6) 2015, THE CONSUMER WAS STILL UNDERGOING TREATMENT WITH THIS PHYSICIAN. AFTER SOME TIME, THE CONSUMER DEVELOPED CHRONIC SINUS INFECTIONS AND FREQUENT HEADACHES. ON UNSPECIFIED DATES, SHE WAS SEEN BY HER PRIMARY CARE PHYSICIAN AND WAS GIVEN TREATMENT FOR THE SINUS INFECTIONS. DUE TO THE NUMBER OF INFECTIONS, SHE WAS THEN REFERRED TO AN EAR, NOSE AND THROAT (ENT)-OTOLARYNGOLOGIST WHO ADVISED A COMPUTED TOMOGRAPHY (CT) SCAN, WHICH INDICATED HER SINUS CAVITY WAS BLOCKED BY A SMALL "CYST-LIKE" MASS. SHE UNDERWENT SINUS SURGERY TO REMOVE THE MASS. DURING THE SUMMER OF 2014, A COSMETIC AND RECONSTRUCTION OCULOPLASTIC SURGEON PERFORMED A SECOND SURGERY TO REMOVE SCAR TISSUE AND LIFT THE STRETCHED SKIN UNDER HER EYES. THE CONSUMER WAS ADVISED THAT IF THE SWELLING CONTINUED, HER SKIN WOULD STRETCH AGAIN. THE CONSUMER WAS ALSO SEEING A NEUROLOGIST FOR THE TREATMENT OF HEADACHES AND MIGRAINES. SHE STATED THAT THE MIGRAINE FELT LIKE A SWELLING IN HER SKULL, WHICH PUT PRESSURE ON HER BRAIN. SHE ALSO REPORTED THAT SHE EXPERIENCED FACIAL SWELLING REGULARLY AND WAS TREATED WITH UNSPECIFIED STEROIDS (DOSE, FREQUENCY AND ROUTE UNSPECIFIED) AT TIMES TO REDUCE THE SWELLING. OVER THE PAST SEVERAL YEARS, SHE HAD NUMEROUS CONSULTATIONS WITH PLASTIC SURGEONS, ALLERGISTS, NATUROPATHS, ACUPUNCTURISTS, LYMPHATIC MASSAGE THERAPISTS, PHYSICAL THERAPISTS, AND CHIROPRACTORS. SHE REPORTED THAT SHE HAD TRIED NUMEROUS SUGGESTED THERAPIES WITH LITTLE OR NO RELIEF AND THE LUMPS HAD CONTINUED TO APPEAR UNDER HER EYES. ONE LUMP MIGRATED TO BLOCK SINUS DRAINAGE CAUSED THE NEED FOR SURGERY AND MULTIPLE LUMPS CAUSED SIGNIFICANT SWELLING AND SCARRING UNDER BOTH EYES RESULTING IN A SECOND SURGERY. SHE NEITHER HAD SWELLING UNDER THE EYES NOR MIGRAINES PRIOR TO DEVICE INJECTION. THE TEST RESULTS AND THE DIAGNOSES FROM THE OTHER DOCTORS WERE NOT REPORTED. SHE DID NOT USE THE DEVICE FURTHER. THE EVENTS WERE NOT RESOLVED. ALL MARKET DISTRIBUTION OF THE DEVICE WAS DISCONTINUED IN 2009 AND THE MANUFACTURER (COLBAR LIFESCIENCE, LTD) HAD SUBSEQUENTLY CLOSED. A LOT NUMBER WAS NOT PROVIDED AND THE COMPLAINT INVESTIGATION WAS CLOSED WITH A DISPOSITION OF UNDETERMINED. THIS REPORT WAS ASSESSED AS SERIOUS AND COMPANY CAUSALITY WAS ASSESSED AS RELATED.
THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6)-2015 FROM A (B)(6)-YEAR-OLD CAUCASIAN FEMALE CONSUMER REPORTING ON SELF FROM THE UNITED STATES. MEDICAL HISTORY INCLUDED SINUS SURGERY, RHEUMATOID ARTHRITIS AND ALLERGIES TO DUST AND MOLD. SHE HAD NO KNOWN FOOD SENSITIVITIES. CONCOMITANT MEDICATIONS INCLUDED MULTIVITAMINS ONE PER DAY FOR UNSPECIFIED YEARS FOR GENERAL HEALTH AND ADVIL (IBUPROFEN) OR SOMETHING SIMILAR AS NEEDED AND PLAQUENIL (HYDROXYCHLOROQUINE) TWO PER DAY, BOTH TAKEN FOR UNSPECIFIED YEARS FOR RHEUMATOID ARTHRITIS. ON AN UNSPECIFIED DATE IN 2009, THE CONSUMER CONSULTED A FACIAL PLASTIC SURGEON. ON THE SAME NIGHT, THE PHYSICIAN INJECTED HER WITH EVOLENCE COLLAGEN FILLER (DOSE, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED) INTRADERMALLY, ONCE IN MULTIPLE LOCATIONS UNDER HER EYES FOR TREATMENT OF "HOLLOWS." DURING ADMINISTRATION, THE PHYSICIAN PRESSED DOWN AND RUBBED THE AREA. POST-INJECTION, SHE EXPERIENCED MINOR BRUISING AND SWELLING. SOON AFTER THE INJECTIONS, SHE BEGAN NOTICING LUMPS/BUMPS UNDER HER EYES. SHE WAS ALSO EXPERIENCING SIGNIFICANT SWELLING THAT LASTED FROM ONE TO THREE DAYS AND THE SWELLING RESOLVED; SHE WAS LEFT WITH BUMPS AND DROOPING, WRINKLED SKIN UNDER HER EYES. ON SEVERAL UNSPECIFIED DATES, SHE RETURNED TO THE PHYSICIAN WHO INJECTED HER WITH THE DEVICE. INITIALLY, SHE WAS ADVISED TO WAIT FOR THE SWELLING AND LUMPS TO GO DOWN AND THEN HER PHYSICIAN SUGGESTED PRESSING ON THE LUMPS. SHE WAS TREATED WITH A SERUM FROM THE PHYSICIAN'S PRODUCT LINE. THE PHYSICIAN ALSO ADVISED STEROID INJECTIONS INTO THE AFFECTED AREA IF SWOLLEN. AS RECENT AS (B)(6)-2015, THE CONSUMER WAS STILL UNDERGOING TREATMENT WITH THIS PHYSICIAN. AFTER SOME TIME, THE CONSUMER DEVELOPED CHRONIC SINUS INFECTIONS AND FREQUENT HEADACHES. ON UNSPECIFIED DATES, SHE WAS SEEN BY HER PRIMARY CARE PHYSICIAN AND WAS GIVEN TREATMENT FOR THE SINUS INFECTIONS. DUE TO THE NUMBER OF INFECTIONS, SHE WAS THEN REFERRED TO AN EAR, NOSE AND THROAT (ENT)-OTOLARYNGOLOGIST WHO ADVISED A COMPUTED TOMOGRAPHY (CT) SCAN, WHICH INDICATED HER SINUS CAVITY WAS BLOCKED BY A SMALL "CYST-LIKE" MASS. SHE UNDERWENT SINUS SURGERY TO REMOVE THE MASS. DURING THE SUMMER OF 2014, A COSMETIC AND RECONSTRUCTION OCULOPLASTIC SURGEON PERFORMED A SECOND SURGERY TO REMOVE SCAR TISSUE AND LIFT THE STRETCHED SKIN UNDER HER EYES. THE CONSUMER WAS ADVISED THAT IF THE SWELLING CONTINUED, HER SKIN WOULD STRETCH AGAIN. ALL MARKET DISTRIBUTION OF THE DEVICE WAS DISCONTINUED IN 2009 AND THE MANUFACTURER (COLBAR LIFESCIENCE, LTD) HAD SUBSEQUENTLY CLOSED. A LOT NUMBER WAS NOT PROVIDED AND THE COMPLAINT INVESTIGATION WAS CLOSED WITH A DISPOSITION OF UNDETERMINED. THIS REPORT WAS ASSESSED AS SERIOUS AND COMPANY CAUSALITY WAS ASSESSED AS RELATED. ADDITIONAL INFORMATION WAS RECEIVED ON 02-MAR-2015. THE CONSUMER WAS (B)(6)-YEARS OLD AT THE ONSET OF THE EVENTS. ADDITIONAL MEDICAL HISTORY INCLUDED ALLERGIC RHINITIS, TUBAL LIGATION (1999), FOCAL ATYPICAL DUCTAL HYPERPLASIA (EXCISION ON (B)(6)-2009), MENOPAUSE, HYPERPARATHYROIDISM, TEMPOROMANDIBULAR JOINT DISORDER, ACNE VULGARIS, AND ALLERGIES TO LATEX AND MEDICAL TAPE. ADDITIONAL CONCOMITANT MEDICATIONS INCLUDED ETODOLAC, BIOIDENTICAL HORMONES, HUMIRA (ADALIMUMAB), PEPTIDE INJECTIONS, FLEXERIL (CYCLOBENZAPRINE), CELEBREX (CELECOXIB), ELOCON (MOMETASONE), AND TRAMADOL. SOCIAL HISTORY INCLUDED OCCASIONAL ALCOHOL CONSUMPTION AND PREVIOUS TOBACCO USE (0.5 PPD FOR 20 YEARS, 1998-2008). THE CONSUMER'S HEIGHT AND RECENT WEIGHT WERE (B)(6). THE CONSUMER WHO WAS IMMUNOSUPPRESSED HAD MULTIPLE CONSULTATIONS WITH VARIOUS PHYSICIANS SINCE 2009 FOR LOWER AND UPPER RESPIRATORY TRACT INFECTIONS INCLUDING CHRONIC SINUSITIS, ACUTE PHARYNGITIS, ASTHMATIC BRONCHITIS, LARYNGITIS, ACUTE BRONCHITIS, EUSTACHIAN TUBE DYSFUNCTION, AND ALLERGIC RHINITIS. SHE WAS TREATED WITH VARIOUS ANTIBIOTICS, STEROIDS, AND OVER THE COUNTER MEDICATIONS (CEFDINIR [(B)(6)-2009], AMOXICILLIN [(B)(6)-2010], CEFPROZIL [(B)(6)-2010], CEFDINIR AND ALBUTEROL [(B)(6)-2010], MOXIFLOXACIN [(B)(6)-2010], LEVOFLOXACIN AND MOMETASONE [(B)(6)-2011], CEFPROZIL [(B)(6)-2011], MOXIFLOXACIN [(B)(6)-2011], CLARITHROMYCIN AND METHYLPREDNISOLONE [(B)(6)-2011], CEFPROZIL, METHYLPREDNISOLONE, MOMETASONE, MONTELUKAST, AZELASTINE [(B)(6)-2011], CEPHALEXIN, METHYLPREDNISOLONE, ACETAMINOPHEN/CODEINE [(B)(6)-2011], PREDNISONE [(B)(6)-2011], PREDNISONE AND CETIRIZINE [(B)(6)-2012], CEFDINIR [(B)(6)-2012], AZITHROMYCIN [(B)(6)-2014], AND CEFPROZIL [(B)(6)-2015]). TREATMENTS ALSO INCLUDING NETI POT, DIPHENHYDRAMINE, FLUTICASONE, PREDNISONE, AND CIPROFLOXACIN FOR CHRONIC MAXILLARY AND ETHMOIDAL SINUSITIS AND S-SHAPED DEVIATED NASAL SEPTUM ON (B)(6)-2011. VARIOUS DIAGNOSTICS AND SURGERIES INCLUDED A CHEST X-RAY ON (B)(6)-2010 SHOWING NO EVIDENCE OF LEFT LOWER LOBE PNEUMONIA AND SINUS X-RAY WITH NO EVIDENCE OF SINUSITIS. PARANASAL SINUSES CT ON (B)(6)-2011 INDICATED INCOMPLETE OPACIFICATION OF THE ETHMOID AND SPHENOID SINUSES. ON (B)(6)-2011, LABORATORY RESULTS WERE UNREMARKABLE WITH THE EXCEPTION OF WBC 12.5 THOUS/ML (3.8-10.8) AND NEUTROPHILS 9163 CELLS/MCL (1500-7800) AND ALLERGY PROFILE WAS POSITIVE FOR DUST MITE ALLERGY. ON (B)(6)-2011, THE CONSUMER WAS SCHEDULED FOR LIPOSUCTION. ON (B)(6)-2011, THE CONSUMER UNDERWENT BILATERAL ENDOSCOPIC BALLOON FRONTAL SINUPLASTY, ETHMOIDECTOMY, ANTROSTOMY, SEPTOPLASTY AND BILATERAL INFERIOR TURBINECTOMY. ON (B)(6)-2012, EPSTEIN-BARR VCA AB AND EBV NUCLEAR AG (EBNA) (IGG) WERE POSITIVE. ON (B)(6)-2012, SHE CONSULTED HER PRIMARY CARE PHYSICIAN DUE TO UNDER EYE SWELLING AND INTERMITTENT SWOLLEN GLANDS UNDER HER ARMS, NECK AND GROIN AND WAS DIAGNOSED WITH POSSIBLE INTERMITTENT LYMPHADENITIS AND XANTHOMAS UNDER HER EYES. ON (B)(6)-2012, AXILLARY ADENOPATHY WAS IDENTIFIED ON HER ANNUAL MEDICAL EXAM AND LABORATORY RESULTS INCLUDING WBC WERE UNREMARKABLE. ON (B)(6)-2013 MAXIOFACIAL SINUS CT RESULTS WERE NORMAL. BRAIN MAGNETIC RESONANCE IMAGING (MRI-3T) ON (B)(6)-2014 WAS PERFORMED DUE TO HISTORY OF MIGRAINES AND FACIAL INFLAMMATION AND IMPRESSION INCLUDED MINIMAL NONSPECIFIC, SUBCORTICAL AND PERIVENTRICULAR FLAIR HYPERINTENSITIES, WHICH COULD BE SEEN WITH MIGRAINE AND SMALL VESSEL ISCHEMIC CHANGE. ANOTHER MRI-3T ON (B)(6)-2014 SHOWED PINEAL REGION MASS WITH IMAGING CHARACTERISTICS MOST CONSISTENT WITH A SEPTATED PINEAL CYST. ON (B)(6)-2014 LYME DISEASE SCREENING WAS NEGATIVE. ON (B)(6)-2014, THE CONSUMER HAD A NEUROLOGICAL CONSULT AND WAS DIAGNOSED WITH MIGRAINE OR CHRONIC DAILY HEADACHE, WHICH WAS SEVERE 2-3 TIMES/WEEK AND WAS PRESCRIBED TOPIRAMATE. ON (B)(6)-2014, THE CONSUMER UNDERWENT FACIAL SURGERY AROUND EYES. ON (B)(6)-2015, THE CONSUMER UNDERWENT LS SPINE X-RAY/OBLIQUES, PELVIS X-RAY, RESULTS OF WHICH WERE NORMAL, SHE ALSO UNDERWENT SINUS CT THAT SHOWED LEFTWARD BOWING OF NASAL SEPTUM, SINOSAL ANATOMIC VARIATIONS IN THE CONFIGURATIONS OF THE DRAINAGE PATHWAYS. THIS REPORT REMAINS SERIOUS. ADDITIONAL INFORMATION WAS RECEIVED ON 27-MAR-2015. ADDITIONAL MEDICAL HISTORY INCLUDED VIRAL MENINGITIS (1986), INSOMNIA, DRY EYE SYNDROME, ROSACEA, ABNORMAL BLEEDING TENDENCY AND EASY BRUISING AND SINUS INFECTIONS ON OCCASION. COSMETIC PROCEDURES INCLUDED BOTOX IN HER FOREHEAD AND MICRODERMABRASION (2004), FACIAL DERMAL FILLERS, AND LASER HAIR REMOVAL ((B)(6)-2009). ADDITIONAL ALLERGIES INCLUDED STRAWBERRIES, ENVIRONMENTAL, SEASONAL, AND UNSPECIFIED FOOD ALLERGIES. ADDITIONAL CONCOMITANT MEDICATIONS INCLUDED RESTASIS (CYCLOSPORINE), RETIN-A (TRETINOIN), NORITATE (METRONIDAZOLE), CALCIUM, VITAMIN D, AND SEQUOIA, RUBES AND RIBES EXTRACTS. ON (B)(6)-2009, THE CONSUMER WAS INJECTED WITH EVOLENCE COLLAGEN FILLER. FOLLOWING ADMINISTRATION, THE CONSUMER HAD NUMEROUS CONSULTATIONS WITH THE SAME PHYSICIAN BECAUSE OF THE BUMPS/LUMPS SHE DEVELOPED UNDER HER EYES. UPON FOLLOW-UP ON (B)(6)-2010, FILLER DEPOSITS WERE VISIBLE IN THE MID RIGHT ORBITAL RIM AND MID AND LEFT LATERAL ORBITAL RIM AND KENNALOG (TRIAMCINOLONE) 0.2 MILLILITERS WAS INJECTED INTO THE THREE DEPOSITS. ON (B)(6)-2010, EXAMINATION REVEALED NO VISIBLE OR PALPABLE DEPOSITS AND THE SAME PHYSICIAN DISCUSSED RESTYLANE (NON-ANIMAL STABILIZED HYALURONIC ACID) INTO THE PERIORBITAL . ON (B)(6)-2011, THE PHYSICIAN ASSESSED THE LATERAL ORBITAL RIM RIGHT TWO DEPOSITS WERE TWO MM IN SIZE AND DIMINISHED GREATLY FROM PRIOR CONSULT. ON (B)(6)-2013, THE CONSUMER CONSULTED THE SAME PHYSICIAN REGARDING THE EXCESS SKIN UNDER HER EYES DUE TO INTERMITTENT STRETCHING AND SWELLING, WHICH WAS ASSESSED AS INTERMITTENT LYMPHATIC EDEMA. ON (B)(6)-2014, SHE CONSULTED WITH A COSMETIC AND RECONSTRUCTIVE EYE AND FACIAL PLASTIC SURGEON DUE TO UNDER HER EYES WERE SWELLING UNDER HER EYES WITH THROBBING PAIN AND PERIPHERAL VISUAL ACUITY LOSS FOR ONE TO TWO YEARS AND WAS DIAGNOSED WITH DERMATOCHALASIS. VISUAL ACUITY WAS 20/20 FOR BOTH EYES. ON (B)(6)-2014, SHE UNDERWENT COSMETIC BLEPHAROPLASTY OF LOWER EYELIDS. SHE HAD OTHER REGULAR CONSULTATIONS WITH A RHEUMATOLOGIST AND AN ALLERGIST, WHO RECOMMENDED ADDING ANTI-INFLAMMATORY DRUGS AND ANTI-DEPRESSANTS SUCH AS CYMBALTA (DULOXETINE) AND FLEXERIL (CYCLOBENZAPRINE), AND CONTINUING UNSPECIFIED ALLERGY SHOTS AND ALLERGY MEDICINE, RESPECTIVELY. THIS REPORT REMAINS SERIOUS. ADDITIONAL INFORMATION WAS RECEIVED ON 05-MAY-2015. ON (B)(6)-2015, THE CONSUMER UNDERWENT CT-MAXIFACIAL SINUS WITHOUT CONTRAST (COMPUTED TOMOGRAPHY) WHICH SHOWED NO EVIDENCE OF ACTIVE INFLAMMATORY DISEASE IN THE PARANASAL SINUSES OR THEIR RESPECTIVE DRAINAGE PATHWAYS. SINONASAL ANATOMIC VARIATIONS IN THE CONFIGURATIONS OF THE DRAINAGE PATHWAYS WERE NOTED WHICH MIGHT PREDISPOSE THE PATIENT TO RECURRENT EPISODES OF INFLAMMATORY DISEASE. THERE WAS WIDELY PATENT BILATERAL MAXILLARY ANTROSTOMIES AND NO EVIDENCE OF NASAL POLYPOSIS. ENLARGED PERIAPICAL CYST SURROUNDING THE ROOTS OF THE LEFT SECOND MAXILLARY MOLAR WAS NOTED WHICH HAS UNDERGONE A PRIOR ENDODONTIC PROCEDURE. THIS REPORT REMAINS SERIOUS.
THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2015 FROM A (B)(6) CAUCASIAN FEMALE CONSUMER REPORTING ON SELF FROM THE UNITED STATES. MEDICAL HISTORY INCLUDED SINUS SURGERY, RHEUMATOID ARTHRITIS AND ALLERGIES TO DUST AND MOLD. SHE HAD NO KNOWN FOOD SENSITIVITIES. CONCOMITANT MEDICATIONS INCLUDED MULTIVITAMINS ONE PER DAY FOR UNSPECIFIED YEARS FOR GENERAL HEALTH AND ADVIL (IBUPROFEN) OR SOMETHING SIMILAR AS NEEDED AND PLAQUENIL (HYDROXYCHLOROQUINE) TWO PER DAY, BOTH TAKEN FOR UNSPECIFIED YEARS FOR RHEUMATOID ARTHRITIS. ON AN UNSPECIFIED DATE IN 2009, THE CONSUMER CONSULTED A FACIAL PLASTIC SURGEON. ON THE SAME NIGHT, THE PHYSICIAN INJECTED HER WITH EVOLENCE COLLAGEN FILLER (DOSE, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED) INTRADERMALLY, ONCE IN MULTIPLE LOCATIONS UNDER HER EYES FOR TREATMENT OF "HOLLOWS". DURING ADMINISTRATION, THE PHYSICIAN PRESSED DOWN AND RUBBED THE AREA. POST-INJECTION, SHE EXPERIENCED MINOR BRUISING AND SWELLING. SOON AFTER THE INJECTIONS, SHE BEGAN NOTICING LUMPS/BUMPS UNDER HER EYES. SHE WAS ALSO EXPERIENCING SIGNIFICANT SWELLING THAT LASTED FROM ONE TO THREE DAYS AND THE SWELLING RESOLVED; SHE WAS LEFT WITH BUMPS AND DROOPING, WRINKLED SKIN UNDER HER EYES. ON SEVERAL UNSPECIFIED DATES, SHE RETURNED TO THE PHYSICIAN WHO INJECTED HER WITH THE DEVICE. INITIALLY, SHE WAS ADVISED TO WAIT FOR THE SWELLING AND LUMPS TO GO DOWN AND THEN HER PHYSICIAN SUGGESTED PRESSING ON THE LUMPS. SHE WAS TREATED WITH A SERUM FROM THE PHYSICIAN'S PRODUCT LINE. THE PHYSICIAN ALSO ADVISED STEROID INJECTIONS INTO THE AFFECTED AREA IF SWOLLEN. AS RECENT AS (B)(6) 2015, THE CONSUMER WAS STILL UNDERGOING TREATMENT WITH THIS PHYSICIAN. AFTER SOME TIME, THE CONSUMER DEVELOPED CHRONIC SINUS INFECTIONS AND FREQUENT HEADACHES. ON UNSPECIFIED DATES, SHE WAS SEEN BY HER PRIMARY CARE PHYSICIAN AND WAS GIVEN TREATMENT FOR THE SINUS INFECTIONS. DUE TO THE NUMBER OF INFECTIONS, SHE WAS THEN REFERRED TO AN EAR, NOSE AND THROAT (ENT)-OTOLARYNGOLOGIST WHO ADVISED A COMPUTED TOMOGRAPHY (CT) SCAN, WHICH INDICATED HER SINUS CAVITY WAS BLOCKED BY A SMALL "CYST-LIKE" MASS. SHE UNDERWENT SINUS SURGERY TO REMOVE THE MASS. DURING THE SUMMER OF 2014, A COSMETIC AND RECONSTRUCTION OCULOPLASTIC SURGEON PERFORMED A SECOND SURGERY TO REMOVE SCAR TISSUE AND LIFT THE STRETCHED SKIN UNDER HER EYES. THE CONSUMER WAS ADVISED THAT IF THE SWELLING CONTINUED, HER SKIN WOULD STRETCH AGAIN. ALL MARKET DISTRIBUTION OF THE DEVICE WAS DISCONTINUED IN 2009 AND THE MANUFACTURER (COLBAR LIFESCIENCE, LTD) HAD SUBSEQUENTLY CLOSED. A LOT NUMBER WAS NOT PROVIDED AND THE COMPLAINT INVESTIGATION WAS CLOSED WITH A DISPOSITION OF UNDETERMINED. THIS REPORT WAS ASSESSED AS SERIOUS AND COMPANY CAUSALITY WAS ASSESSED AS RELATED. ADDITIONAL INFORMATION WAS RECEIVED ON 02-MAR-2015. THE CONSUMER WAS (B)(6) AT THE ONSET OF THE EVENTS. ADDITIONAL MEDICAL HISTORY INCLUDED ALLERGIC RHINITIS, TUBAL LIGATION (1999), FOCAL ATYPICAL DUCTAL HYPERPLASIA (EXCISION ON (B)(6) 2009), MENOPAUSE, HYPERPARATHYROIDISM, TEMPOROMANDIBULAR JOINT DISORDER, ACNE VULGARIS, AND ALLERGIES TO LATEX AND MEDICAL TAPE. ADDITIONAL CONCOMITANT MEDICATIONS INCLUDED ETODOLAC, BIOIDENTICAL HORMONES, HUMIRA (ADALIMUMAB), PEPTIDE INJECTIONS, FLEXERIL (CYCLOBENZAPRINE), CELEBREX (CELECOXIB), ELOCON (MOMETASONE), AND TRAMADOL. SOCIAL HISTORY INCLUDED OCCASIONAL ALCOHOL CONSUMPTION AND PREVIOUS TOBACCO USE (0.5 PPD FOR 20 YEARS, 1998-2008). THE CONSUMER'S HEIGHT AND RECENT WEIGHT WERE (B)(6), RESPECTIVELY. THE CONSUMER WHO WAS IMMUNOSUPPRESSED HAD MULTIPLE CONSULTATIONS WITH VARIOUS PHYSICIANS SINCE 2009 FOR LOWER AND UPPER RESPIRATORY TRACT INFECTIONS INCLUDING CHRONIC SINUSITIS, ACUTE PHARYNGITIS, ASTHMATIC BRONCHITIS, LARYNGITIS, ACUTE BRONCHITIS, EUSTACHIAN TUBE DYSFUNCTION, AND ALLERGIC RHINITIS. SHE WAS TREATED WITH VARIOUS ANTIBIOTICS, STEROIDS, AND OVER THE COUNTER MEDICATIONS (CEFDINIR [(B)(6) 2009], AMOXICILLIN [(B)(6) 2010], CEFPROZIL [(B)(6) 2010], CEFDINIR AND ALBUTEROL [(B)(6) 2010], MOXIFLOXACIN [(B)(6) 2010], LEVOFLOXACIN AND MOMETASONE [(B)(6) 2011], CEFPROZIL [(B)(6) 2011], MOXIFLOXACIN [(B)(6) 2011], CLARITHROMYCIN AND METHYLPREDNISOLONE [(B)(6) 2011], CEFPROZIL, METHYLPREDNISOLONE, MOMETASONE, MONTELUKAST, AZELASTINE [(B)(6) 2011], CEPHALEXIN, METHYLPREDNISOLONE, ACETAMINOPHEN/CODEINE [(B)(6) 2011], PREDNISONE [(B)(6) 2011], PREDNISONE AND CETIRIZINE [(B)(6) 2012], CEFDINIR [(B)(6) 2012], AZITHROMYCIN [(B)(6) 2014], AND CEFPROZIL [(B)(6) 2015]). TREATMENTS ALSO INCLUDING NETI POT, DIPHENHYDRAMINE, FLUTICASONE, PREDNISONE, AND CIPROFLOXACIN FOR CHRONIC MAXILLARY AND ETHMOIDAL SINUSITIS AND S-SHAPED DEVIATED NASAL SEPTUM ON (B)(6) 2011. VARIOUS DIAGNOSTICS AND SURGERIES INCLUDED A CHEST X-RAY ON (B)(6) 2010 SHOWING NO EVIDENCE OF LEFT LOWER LOBE PNEUMONIA AND SINUS X-RAY WITH NO EVIDENCE OF SINUSITIS. PARANASAL SINUSES CT ON (B)(6) 2011 INDICATED INCOMPLETE OPACIFICATION OF THE ETHMOID AND SPHENOID SINUSES. ON (B)(6) 2011, LABORATORY RESULTS WERE UNREMARKABLE WITH THE EXCEPTION OF WBC 12.5 THOUS/ML (3.8-10.8) AND NEUTROPHILS 9163 CELLS/MCL (1500-7800) AND ALLERGY PROFILE WAS POSITIVE FOR DUST MITE ALLERGY. ON (B)(6) 2011, THE CONSUMER WAS SCHEDULED FOR LIPOSUCTION. ON (B)(6) 2011, THE CONSUMER UNDERWENT BILATERAL ENDOSCOPIC BALLOON FRONTAL SINUPLASTY, ETHMOIDECTOMY, ANTROSTOMY, SEPTOPLASTY AND BILATERAL INFERIOR TURBINECTOMY. ON (B)(6) 2012, EPSTEIN-BARR VCA AB AND EBV NUCLEAR AG (EBNA) (IGG) WERE POSITIVE. ON (B)(6) 2012, SHE CONSULTED HER PRIMARY CARE PHYSICIAN DUE TO UNDER EYE SWELLING AND INTERMITTENT SWOLLEN GLANDS UNDER HER ARMS, NECK AND GROIN AND WAS DIAGNOSED WITH POSSIBLE INTERMITTENT LYMPHADENITIS AND XANTHOMAS UNDER HER EYES. ON (B)(6) 2012, AXILLARY ADENOPATHY WAS IDENTIFIED ON HER ANNUAL MEDICAL EXAM AND LABORATORY RESULTS INCLUDING WBC WERE UNREMARKABLE. ON (B)(6) 2013 MAXIOFACIAL SINUS CT RESULTS WERE NORMAL. BRAIN MAGNETIC RESONANCE IMAGING (MRI-3T) ON (B)(6) 2014 WAS PERFORMED DUE TO HISTORY OF MIGRAINES AND FACIAL INFLAMMATION AND IMPRESSION INCLUDED MINIMAL NONSPECIFIC, SUBCORTICAL AND PERIVENTRICULAR FLAIR HYPERINTENSITIES, WHICH COULD BE SEEN WITH MIGRAINE AND SMALL VESSEL ISCHEMIC CHANGE. ANOTHER MRI-3T ON (B)(6) 2014 SHOWED PINEAL REGION MASS WITH IMAGING CHARACTERISTICS MOST CONSISTENT WITH A SEPTATED PINEAL CYST. ON (B)(6) 2014 LYME DISEASE SCREENING WAS NEGATIVE. ON (B)(6) 2014, THE CONSUMER HAD A NEUROLOGICAL CONSULT AND WAS DIAGNOSED WITH MIGRAINE OR CHRONIC DAILY HEADACHE, WHICH WAS SEVERE 2-3 TIMES/WEEK AND WAS PRESCRIBED TOPIRAMATE. ON (B)(6) 2014, THE CONSUMER UNDERWENT FACIAL SURGERY AROUND EYES. ON (B)(6) 2015, THE CONSUMER UNDERWENT LS SPINE X-RAY/OBLIQUES, PELVIS X-RAY, RESULTS OF WHICH WERE NORMAL, SHE ALSO UNDERWENT SINUS CT THAT SHOWED LEFTWARD BOWING OF NASAL SEPTUM, SINOSAL ANATOMIC VARIATIONS IN THE CONFIGURATIONS OF THE DRAINAGE PATHWAYS. THIS REPORT REMAINS SERIOUS. ADDITIONAL INFORMATION WAS RECEIVED ON 27-MAR-2015. ADDITIONAL MEDICAL HISTORY INCLUDED VIRAL MENINGITIS (1986), INSOMNIA, DRY EYE SYNDROME, ROSACEA, ABNORMAL BLEEDING TENDENCY AND EASY BRUISING AND SINUS INFECTIONS ON OCCASION. COSMETIC PROCEDURES INCLUDED BOTOX IN HER FOREHEAD AND MICRODERMABRASION (2004), FACIAL DERMAL FILLERS, AND LASER HAIR REMOVAL ((B)(6) 2009). ADDITIONAL ALLERGIES INCLUDED STRAWBERRIES, ENVIRONMENTAL, SEASONAL, AND UNSPECIFIED FOOD ALLERGIES. ADDITIONAL CONCOMITANT MEDICATIONS INCLUDED RESTASIS (CYCLOSPORINE), RETIN-A (TRETINOIN), NORITATE (METRONIDAZOLE), CALCIUM, VITAMIN D, AND SEQUOIA, RUBES AND RIBES EXTRACTS. ON (B)(6) 2009, THE CONSUMER WAS INJECTED WITH EVOLENCE COLLAGEN FILLER. FOLLOWING ADMINISTRATION, THE CONSUMER HAD NUMEROUS CONSULTATIONS WITH THE SAME PHYSICIAN BECAUSE OF THE BUMPS/LUMPS SHE DEVELOPED UNDER HER EYES. UPON FOLLOW-UP ON (B)(6) 2010, FILLER DEPOSITS WERE VISIBLE IN THE MID RIGHT ORBITAL RIM AND MID AND LEFT LATERAL ORBITAL RIM AND KENNALOG (TRIAMCINOLONE) 0.2 MILLILITERS WAS INJECTED INTO THE THREE DEPOSITS. ON (B)(6) 2010, EXAMINATION REVEALED NO VISIBLE OR PALPABLE DEPOSITS AND THE SAME PHYSICIAN DISCUSSED RESTYLANE (NON-ANIMAL STABILIZED HYALURONIC ACID) INTO THE PERIORBITAL . ON (B)(6) 2011, THE PHYSICIAN ASSESSED THE LATERAL ORBITAL RIM RIGHT TWO DEPOSITS WERE TWO MM IN SIZE AND DIMINISHED GREATLY FROM PRIOR CONSULT. ON (B)(6) 2013, THE CONSUMER CONSULTED THE SAME PHYSICIAN REGARDING THE EXCESS SKIN UNDER HER EYES DUE TO INTERMITTENT STRETCHING AND SWELLING, WHICH WAS ASSESSED AS INTERMITTENT LYMPHATIC EDEMA. ON (B)(6) 2014, SHE CONSULTED WITH A COSMETIC AND RECONSTRUCTIVE EYE AND FACIAL PLASTIC SURGEON DUE TO UNDER HER EYES WERE SWELLING UNDER HER EYES WITH THROBBING PAIN AND PERIPHERAL VISUAL ACUITY LOSS FOR ONE TO TWO YEARS AND WAS DIAGNOSED WITH DERMATOCHALASIS. VISUAL ACUITY WAS 20/20 FOR BOTH EYES. ON (B)(6) 2014, SHE UNDERWENT COSMETIC BLEPHAROPLASTY OF LOWER EYELIDS. SHE HAD OTHER REGULAR CONSULTATIONS WITH A RHEUMATOLOGIST AND AN ALLERGIST, WHO RECOMMENDED ADDING ANTI-INFLAMMATORY DRUGS AND ANTI-DEPRESSANTS SUCH AS CYMBALTA (DULOXETINE) AND FLEXERIL (CYCLOBENZAPRINE), AND CONTINUING UNSPECIFIED ALLERGY SHOTS AND ALLERGY MEDICINE, RESPECTIVELY. THIS REPORT REMAINS SERIOUS. ADDITIONAL INFORMATION WAS RECEIVED ON 05-MAY-2015. ON (B)(6) 2015, THE CONSUMER UNDERWENT CT-MAXIFACIAL SINUS WITHOUT CONTRAST (COMPUTED TOMOGRAPHY) WHICH SHOWED NO EVIDENCE OF ACTIVE INFLAMMATORY DISEASE IN THE PARANASAL SINUSES OR THEIR RESPECTIVE DRAINAGE PATHWAYS. SINONASAL ANATOMIC VARIATIONS IN THE CONFIGURATIONS OF THE DRAINAGE PATHWAYS WERE NOTED WHICH MIGHT PREDISPOSE THE PATIENT TO RECURRENT EPISODES OF INFLAMMATORY DISEASE. THERE WAS WIDELY PATENT BILATERAL MAXILLARY ANTROSTOMIES AND NO EVIDENCE OF NASAL POLYPOSIS. ENLARGED PERIAPICAL CYST SURROUNDING THE ROOTS OF THE LEFT SECOND MAXILLARY MOLAR WAS NOTED WHICH HAS UNDERGONE A PRIOR ENDODONTIC PROCEDURE. THIS REPORT REMAINS SERIOUS. ADDITIONAL INFORMATION WAS RECEIVED ON 21-MAY-2015. ON (B)(6) 2014, THE CONSUMER UNDERWENT TRANSCRANIAL DOPPLER (TCD) BECAUSE SHE HAD SYMPTOMS RELATABLE TO VERTEBROBASILAR INSUFFICIENCY (VBI). THE STUDY CONFIRMED THE PATENCY OF THE MAJOR BASAL INTRACRANIAL ARTERIES ON THE CIRCLE OF WILLIS. THERE WAS NO EVIDENCE OF INTRACRANIAL STENOSIS OR OCCLUSIVE DISEASE. VASOMOTOR REACTIVITY (VMR) TESTING SHOWED NORMAL VASODILATOR REACTIVITY IN THE BASILAR ARTERY. ON (B)(6) 2014, SHE HAD A FOLLOW-UP NEUROLOGICAL CONSULT AND CONTINUED TO COMPLAIN OF HEADACHE AND REPORTED TO HAVE TRIED USING TOPAMAX (TOPIRAMATE). ON (B)(6) 2014, SHE STATED THAT TOPAMAX WAS INEFFECTIVE FOR HER MIGRAINE DURING HER CONSULTATION WITH THE SAME NEUROLOGIST. ON (B)(6) 2014, SHE HAD ANOTHER FOLLOW-UP AND SHE STILL COMPLAINED OF HEADACHE BUT SHE EXPERIENCED RELIEF FROM TAKING MAXALT (RIZATRIPTAN) AS NEEDED. ON (B)(6) 2014, SHE WAS ADMINISTERED WITH BOTOX INJECTION 155 UNITS INTRAMUSCULARLY IN DIFFERENT SITES FOR CHRONIC MIGRAINE TREATMENT. ON (B)(6) 2014, THE HEADACHES WERE REDUCED BY 50% AND LASTED LESS TIME PER EPISODES. THE TREATMENT OF BOTOX INJECTION WAS REPEATED ON (B)(6) 2015. SHE HAD NECK PAIN AND PTOSIS. THIS REPORT REMAINS SERIOUS.
THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6)-2015 FROM A (B)(6) YEAR-OLD CAUCASIAN FEMALE CONSUMER REPORTING ON SELF FROM THE UNITED STATES.MEDICAL HISTORY INCLUDED SINUS SURGERY, RHEUMATOID ARTHRITIS AND ALLERGIES TO DUST AND MOLD. SHE HAD NO KNOWN FOOD SENSITIVITIES. CONCOMITANT MEDICATIONS INCLUDED MULTIVITAMINS ONE PER DAY FOR UNSPECIFIED YEARS FOR GENERAL HEALTH AND ADVIL (IBUPROFEN) OR SOMETHING SIMILAR AS NEEDED AND PLAQUENIL (HYDROXYCHLOROQUINE) TWO PER DAY, BOTH TAKEN FOR UNSPECIFIED YEARS FOR RHEUMATOID ARTHRITIS.ON AN UNSPECIFIED DATE IN 2009, THE CONSUMER CONSULTED A FACIAL PLASTIC SURGEON. ON THE SAME NIGHT, THE PHYSICIAN INJECTED HER WITH EVOLENCE COLLAGEN FILLER (DOSE, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED) INTRADERMALLY, ONCE IN MULTIPLE LOCATIONS UNDER HER EYES FOR TREATMENT OF "HOLLOWS." DURING ADMINISTRATION, THE PHYSICIAN PRESSED DOWN AND RUBBED THE AREA. POST-INJECTION, SHE EXPERIENCED MINOR BRUISING AND SWELLING. SOON AFTER THE INJECTIONS, SHE BEGAN NOTICING LUMPS/BUMPS UNDER HER EYES. SHE WAS ALSO EXPERIENCING SIGNIFICANT SWELLING THAT LASTED FROM ONE TO THREE DAYS AND THE SWELLING RESOLVED; SHE WAS LEFT WITH BUMPS AND DROOPING, WRINKLED SKIN UNDER HER EYES. ON SEVERAL UNSPECIFIED DATES, SHE RETURNED TO THE PHYSICIAN WHO INJECTED HER WITH THE DEVICE. INITIALLY, SHE WAS ADVISED TO WAIT FOR THE SWELLING AND LUMPS TO GO DOWN AND THEN HER PHYSICIAN SUGGESTED PRESSING ON THE LUMPS. SHE WAS TREATED WITH A SERUM FROM THE PHYSICIAN'S PRODUCT LINE. THE PHYSICIAN ALSO ADVISED STEROID INJECTIONS INTO THE AFFECTED AREA IF SWOLLEN. AS RECENT AS (B)(6)-2015, THE CONSUMER WAS STILL UNDERGOING TREATMENT WITH THIS PHYSICIAN. AFTER SOME TIME, THE CONSUMER DEVELOPED CHRONIC SINUS INFECTIONS AND FREQUENT HEADACHES. ON UNSPECIFIED DATES, SHE WAS SEEN BY HER PRIMARY CARE PHYSICIAN AND WAS GIVEN TREATMENT FOR THE SINUS INFECTIONS. DUE TO THE NUMBER OF INFECTIONS, SHE WAS THEN REFERRED TO AN EAR, NOSE AND THROAT (ENT)-OTOLARYNGOLOGIST WHO ADVISED A COMPUTED TOMOGRAPHY (CT) SCAN, WHICH INDICATED HER SINUS CAVITY WAS BLOCKED BY A SMALL CYST-LIKE MASS. SHE UNDERWENT SINUS SURGERY TO REMOVE THE MASS. DURING THE SUMMER OF 2014, A COSMETIC AND RECONSTRUCTION OCULOPLASTIC SURGEON PERFORMED A SECOND SURGERY TO REMOVE SCAR TISSUE AND LIFT THE STRETCHED SKIN UNDER HER EYES. THE CONSUMER WAS ADVISED THAT IF THE SWELLING CONTINUED, HER SKIN WOULD STRETCH AGAIN. ALL MARKET DISTRIBUTION OF THE DEVICE WAS DISCONTINUED IN 2009 AND THE MANUFACTURER (COLBAR LIFESCIENCE, LTD) HAD SUBSEQUENTLY CLOSED. A LOT NUMBER WAS NOT PROVIDED AND THE COMPLAINT INVESTIGATION WAS CLOSED WITH A DISPOSITION OF UNDETERMINED.THIS REPORT WAS ASSESSED AS SERIOUS AND COMPANY CAUSALITY WAS ASSESSED AS RELATED.ADDITIONAL INFORMATION WAS RECEIVED ON 02-MAR-2015. THE CONSUMER WAS (B)(6)-YEARS OLD AT THE ONSET OF THE EVENTS. ADDITIONAL MEDICAL HISTORY INCLUDED ALLERGIC RHINITIS, TUBAL LIGATION (1999), FOCAL ATYPICAL DUCTAL HYPERPLASIA (EXCISION ON (B)(6)-2009), MENOPAUSE, HYPERPARATHYROIDISM, TEMPOROMANDIBULAR JOINT DISORDER, ACNE VULGARIS, AND ALLERGIES TO LATEX AND MEDICAL TAPE. ADDITIONAL CONCOMITANT MEDICATIONS INCLUDED ETODOLAC, BIOIDENTICAL HORMONES, HUMIRA (ADALIMUMAB), PEPTIDE INJECTIONS, FLEXERIL (CYCLOBENZAPRINE), CELEBREX (CELECOXIB), ELOCON (MOMETASONE), AND TRAMADOL. SOCIAL HISTORY INCLUDED OCCASIONAL ALCOHOL CONSUMPTION AND PREVIOUS TOBACCO USE (0.5 PPD FOR 20 YEARS, 1998-2008). THE CONSUMER'S HEIGHT AND RECENT WEIGHT WERE (B)(6), RESPECTIVELY. THE CONSUMER WHO WAS IMMUNOSUPPRESSED HAD MULTIPLE CONSULTATIONS WITH VARIOUS PHYSICIANS SINCE 2009 FOR LOWER AND UPPER RESPIRATORY TRACT INFECTIONS INCLUDING CHRONIC SINUSITIS, ACUTE PHARYNGITIS, ASTHMATIC BRONCHITIS, LARYNGITIS, ACUTE BRONCHITIS, EUSTACHIAN TUBE DYSFUNCTION, AND ALLERGIC RHINITIS. SHE WAS TREATED WITH VARIOUS ANTIBIOTICS, STEROIDS, AND OVER THE COUNTER MEDICATIONS (CEFDINIR [(B)(6)-2009], AMOXICILLIN [(B)(6)-2010], CEFPROZIL [(B)(6)-2010], CEFDINIR AND ALBUTEROL [(B)(6)-2010], MOXIFLOXACIN [(B)(6)-2010], LEVOFLOXACIN AND MOMETASONE [(B)(6)-2011], CEFPROZIL [(B)(6)-2011], MOXIFLOXACIN [(B)(6)-2011], CLARITHROMYCIN AND METHYLPREDNISOLONE [(B)(6)-2011], CEFPROZIL, METHYLPREDNISOLONE, MOMETASONE, MONTELUKAST, AZELASTINE [(B)(6)-2011], CEPHALEXIN, METHYLPREDNISOLONE, ACETAMINOPHEN/CODEINE [(B)(6)-2011], PREDNISONE [(B)(6)-2011], PREDNISONE AND CETIRIZINE [(B)(6)-2012], CEFDINIR [(B)(6)-2012], AZITHROMYCIN [(B)(6)-2014], AND CEFPROZIL [(B)(6)-2015]). TREATMENTS ALSO INCLUDING NETI POT, DIPHENHYDRAMINE, FLUTICASONE, PREDNISONE, AND CIPROFLOXACIN FOR CHRONIC MAXILLARY AND ETHMOIDAL SINUSITIS AND S-SHAPED DEVIATED NASAL SEPTUM ON (B)(6)-2011. VARIOUS DIAGNOSTICS AND SURGERIES INCLUDED A CHEST X-RAY ON (B)(6)-2010 SHOWING NO EVIDENCE OF LEFT LOWER LOBE PNEUMONIA AND SINUS X-RAY WITH NO EVIDENCE OF SINUSITIS. PARANASAL SINUSES CT ON (B)(6)-2011 INDICATED INCOMPLETE OPACIFICATION OF THE ETHMOID AND SPHENOID SINUSES. ON (B)(6)-2011, LABORATORY RESULTS WERE UNREMARKABLE WITH THE EXCEPTION OF WBC 12.5 THOUS/ML (3.8-10.8) AND NEUTROPHILS 9163 CELLS/MCL (1500-7800) AND ALLERGY PROFILE WAS POSITIVE FOR DUST MITE ALLERGY. ON (B)(6)-2011, THE CONSUMER WAS SCHEDULED FOR LIPOSUCTION. ON (B)(6)-2011, THE CONSUMER UNDERWENT BILATERAL ENDOSCOPIC BALLOON FRONTAL SINUPLASTY, ETHMOIDECTOMY, ANTROSTOMY, SEPTOPLASTY AND BILATERAL INFERIOR TURBINECTOMY. ON (B)(6)-2012, EPSTEIN-BARR VCA AB AND EBV NUCLEAR AG (EBNA) (IGG) WERE POSITIVE. ON (B)(6)-2012, SHE CONSULTED HER PRIMARY CARE PHYSICIAN DUE TO UNDER EYE SWELLING AND INTERMITTENT SWOLLEN GLANDS UNDER HER ARMS, NECK AND GROIN AND WAS DIAGNOSED WITH POSSIBLE INTERMITTENT LYMPHADENITIS AND XANTHOMAS UNDER HER EYES. ON (B)(6)-2012, AXILLARY ADENOPATHY WAS IDENTIFIED ON HER ANNUAL MEDICAL EXAM AND LABORATORY RESULTS INCLUDING WBC WERE UNREMARKABLE. ON (B)(6)-2013 MAXIOFACIAL SINUS CT RESULTS WERE NORMAL. BRAIN MAGNETIC RESONANCE IMAGING (MRI-3T) ON (B)(6)-2014 WAS PERFORMED DUE TO HISTORY OF MIGRAINES AND FACIAL INFLAMMATION AND IMPRESSION INCLUDED MINIMAL NONSPECIFIC, SUBCORTICAL AND PERIVENTRICULAR FLAIR HYPERINTENSITIES, WHICH COULD BE SEEN WITH MIGRAINE AND SMALL VESSEL ISCHEMIC CHANGE. ANOTHER MRI-3T ON (B)(6)-2014 SHOWED PINEAL REGION MASS WITH IMAGING CHARACTERISTICS MOST CONSISTENT WITH A SEPTATED PINEAL CYST. ON (B)(6)-2014 LYME DISEASE SCREENING WAS NEGATIVE. ON (B)(6)-2014, THE CONSUMER HAD A NEUROLOGICAL CONSULT AND WAS DIAGNOSED WITH MIGRAINE OR CHRONIC DAILY HEADACHE, WHICH WAS SEVERE 2-3 TIMES/WEEK AND WAS PRESCRIBED TOPIRAMATE. ON (B)(6)-2014, THE CONSUMER UNDERWENT FACIAL SURGERY AROUND EYES. ON (B)(6)-2015, THE CONSUMER UNDERWENT LS SPINE X-RAY/OBLIQUES, PELVIS X-RAY, RESULTS OF WHICH WERE NORMAL, SHE ALSO UNDERWENT SINUS CT THAT SHOWED LEFTWARD BOWING OF NASAL SEPTUM, SINOSAL ANATOMIC VARIATIONS IN THE CONFIGURATIONS OF THE DRAINAGE PATHWAYS.THIS REPORT REMAINS SERIOUS.ADDITIONAL INFORMATION WAS RECEIVED ON 27-MAR-2015.ADDITIONAL MEDICAL HISTORY INCLUDED VIRAL MENINGITIS (1986), INSOMNIA, DRY EYE SYNDROME, ROSACEA, ABNORMAL BLEEDING TENDENCY AND EASY BRUISING AND SINUS INFECTIONS ON OCCASION. COSMETIC PROCEDURES INCLUDED BOTOX IN HER FOREHEAD AND MICRODERMABRASION (2004), FACIAL DERMAL FILLERS, AND LASER HAIR REMOVAL ((B)(6)-2009). ADDITIONAL ALLERGIES INCLUDED STRAWBERRIES, ENVIRONMENTAL, SEASONAL, AND UNSPECIFIED FOOD ALLERGIES. ADDITIONAL CONCOMITANT MEDICATIONS INCLUDED RESTASIS (CYCLOSPORINE), RETIN-A (TRETINOIN), NORITATE (METRONIDAZOLE), CALCIUM, VITAMIN D, AND SEQUOIA, RUBES AND RIBES EXTRACTS. ON (B)(6)-2009, THE CONSUMER WAS INJECTED WITH EVOLENCE COLLAGEN FILLER. FOLLOWING ADMINISTRATION, THE CONSUMER HAD NUMEROUS CONSULTATIONS WITH THE SAME PHYSICIAN BECAUSE OF THE BUMPS/LUMPS SHE DEVELOPED UNDER HER EYES. UPON FOLLOW-UP ON (B)(6)-2010, FILLER DEPOSITS WERE VISIBLE IN THE MID RIGHT ORBITAL RIM AND MID AND LEFT LATERAL ORBITAL RIM AND KENNALOG (TRIAMCINOLONE) 0.2 MILLILITERS WAS INJECTED INTO THE THREE DEPOSITS. ON (B)(6)-2010, EXAMINATION REVEALED NO VISIBLE OR PALPABLE DEPOSITS AND THE SAME PHYSICIAN DISCUSSED RESTYLANE (NON-ANIMAL STABILIZED HYALURONIC ACID) INTO THE PERIORBITAL . ON (B)(6)-2011, THE PHYSICIAN ASSESSED THE LATERAL ORBITAL RIM RIGHT TWO DEPOSITS WERE TWO MM IN SIZE AND DIMINISHED GREATLY FROM PRIOR CONSULT. ON (B)(6)-2013, THE CONSUMER CONSULTED THE SAME PHYSICIAN REGARDING THE EXCESS SKIN UNDER HER EYES DUE TO INTERMITTENT STRETCHING AND SWELLING, WHICH WAS ASSESSED AS INTERMITTENT LYMPHATIC EDEMA. ON (B)(6)-2014, SHE CONSULTED WITH A COSMETIC AND RECONSTRUCTIVE EYE AND FACIAL PLASTIC SURGEON DUE TO UNDER HER EYES WERE SWELLING UNDER HER EYES WITH THROBBING PAIN AND PERIPHERAL VISUAL ACUITY LOSS FOR ONE TO TWO YEARS AND WAS DIAGNOSED WITH DERMATOCHALASIS. VISUAL ACUITY WAS 20/20 FOR BOTH EYES. ON (B)(6)-2014, SHE UNDERWENT COSMETIC BLEPHAROPLASTY OF LOWER EYELIDS. SHE HAD OTHER REGULAR CONSULTATIONS WITH A RHEUMATOLOGIST AND AN ALLERGIST, WHO RECOMMENDED ADDING ANTI-INFLAMMATORY DRUGS AND ANTI-DEPRESSANTS SUCH AS CYMBALTA (DULOXETINE) AND FLEXERIL (CYCLOBENZAPRINE), AND CONTINUING UNSPECIFIED ALLERGY SHOTS AND ALLERGY MEDICINE, RESPECTIVELY. THIS REPORT REMAINS SERIOUS.ADDITIONAL INFORMATION WAS RECEIVED ON 05-MAY-2015.ON (B)(6)-2015, THE CONSUMER UNDERWENT CT-MAXIFACIAL SINUS WITHOUT CONTRAST (COMPUTED TOMOGRAPHY) WHICH SHOWED NO EVIDENCE OF ACTIVE INFLAMMATORY DISEASE IN THE PARANASAL SINUSES OR THEIR RESPECTIVE DRAINAGE PATHWAYS. SINONASAL ANATOMIC VARIATIONS IN THE CONFIGURATIONS OF THE DRAINAGE PATHWAYS WERE NOTED WHICH MIGHT PREDISPOSE THE PATIENT TO RECURRENT EPISODES OF INFLAMMATORY DISEASE. THERE WAS WIDELY PATENT BILATERAL MAXILLARY ANTROSTOMIES AND NO EVIDENCE OF NASAL POLYPOSIS. ENLARGED PERIAPICAL CYST SURROUNDING THE ROOTS OF THE LEFT SECOND MAXILLARY MOLAR WAS NOTED WHICH HAS UNDERGONE A PRIOR ENDODONTIC PROCEDURE. THIS REPORT REMAINS SERIOUS.ADDITIONAL INFORMATION WAS RECEIVED ON 21-MAY-2015.ON (B)(6)-2014, THE CONSUMER UNDERWENT TRANSCRANIAL DOPPLER (TCD) BECAUSE SHE HAD SYMPTOMS RELATABLE TO VERTEBROBASILAR INSUFFICIENCY (VBI). THE STUDY CONFIRMED THE PATENCY OF THE MAJOR BASAL INTRACRANIAL ARTERIES ON THE CIRCLE OF WILLIS. THERE WAS NO EVIDENCE OF INTRACRANIAL STENOSIS OR OCCLUSIVE DISEASE. VASOMOTOR REACTIVITY (VMR) TESTING SHOWED NORMAL VASODILATOR REACTIVITY IN THE BASILAR ARTERY. ON (B)(6)-2014, SHE HAD A FOLLOW-UP NEUROLOGICAL CONSULT AND CONTINUED TO COMPLAIN OF HEADACHE AND REPORTED TO HAVE TRIED USING TOPAMAX (TOPIRAMATE). ON (B)(6)-2014, SHE STATED THAT TOPAMAX WAS INEFFECTIVE FOR HER MIGRAINE DURING HER CONSULTATION WITH THE SAME NEUROLOGIST. ON (B)(6)-2014, SHE HAD ANOTHER FOLLOW-UP AND SHE STILL COMPLAINED OF HEADACHE BUT SHE EXPERIENCED RELIEF FROM TAKING MAXALT (RIZATRIPTAN) AS NEEDED. ON (B)(6)-2014, SHE WAS ADMINISTERED WITH BOTOX INJECTION 155 UNITS INTRAMUSCULARLY IN DIFFERENT SITES FOR CHRONIC MIGRAINE TREATMENT. ON (B)(6)-2014, THE HEADACHES WERE REDUCED BY 50% AND LASTED LESS TIME PER EPISODES. THE TREATMENT OF BOTOX INJECTION WAS REPEATED ON (B)(6)-2015 AND (B)(6)-2015. SHE HAD NECK PAIN AND PTOSIS. THIS REPORT REMAINS SERIOUS.ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL ON 04-JUN-2015.THE CONSUMER HAD ALLERGIES TO CATS, GRASS AND RAGWEED. ON AN UNSPECIFIED DATE, SHE CONSULTED A PEDIATRICIAN, ALLERGY AND IMMUNOLOGY SPECIALIST AND SHE WAS GIVEN AN UNSPECIFIED INJECTION FOR ALLERGIC RHINITIS.THIS REPORT REMAINS SERIOUS.
THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2015 FROM A (B)(6) CAUCASIAN FEMALE CONSUMER REPORTING ON SELF FROM THE UNITED STATES. MEDICAL HISTORY INCLUDED SINUS SURGERY, RHEUMATOID ARTHRITIS AND ALLERGIES TO DUST AND MOLD. SHE HAD NO KNOWN FOOD SENSITIVITIES. CONCOMITANT MEDICATIONS INCLUDED MULTIVITAMINS ONE PER DAY FOR UNSPECIFIED YEARS FOR GENERAL HEALTH AND ADVIL (IBUPROFEN) OR SOMETHING SIMILAR AS NEEDED AND PLAQUENIL (HYDROXYCHLOROQUINE) TWO PER DAY, BOTH TAKEN FOR UNSPECIFIED YEARS FOR RHEUMATOID ARTHRITIS. ON AN UNSPECIFIED DATE IN 2009, THE CONSUMER CONSULTED A FACIAL PLASTIC SURGEON. ON THE SAME NIGHT, THE PHYSICIAN INJECTED HER WITH EVOLENCE COLLAGEN FILLER (DOSE, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED) INTRADERMALLY, ONCE IN MULTIPLE LOCATIONS UNDER HER EYES FOR TREATMENT OF "HOLLOWS". DURING ADMINISTRATION, THE PHYSICIAN PRESSED DOWN AND RUBBED THE AREA. POST-INJECTION, SHE EXPERIENCED MINOR BRUISING AND SWELLING. SOON AFTER THE INJECTIONS, SHE BEGAN NOTICING LUMPS/BUMPS UNDER HER EYES. SHE WAS ALSO EXPERIENCING SIGNIFICANT SWELLING THAT LASTED FROM ONE TO THREE DAYS AND THE SWELLING RESOLVED; SHE WAS LEFT WITH BUMPS AND DROOPING, WRINKLED SKIN UNDER HER EYES. ON SEVERAL UNSPECIFIED DATES, SHE RETURNED TO THE PHYSICIAN WHO INJECTED HER WITH THE DEVICE. INITIALLY, SHE WAS ADVISED TO WAIT FOR THE SWELLING AND LUMPS TO GO DOWN AND THEN HER PHYSICIAN SUGGESTED PRESSING ON THE LUMPS. SHE WAS TREATED WITH A SERUM FROM THE PHYSICIAN'S PRODUCT LINE. THE PHYSICIAN ALSO ADVISED STEROID INJECTIONS INTO THE AFFECTED AREA IF SWOLLEN. AS RECENT AS (B)(6) 2015, THE CONSUMER WAS STILL UNDERGOING TREATMENT WITH THIS PHYSICIAN. AFTER SOME TIME, THE CONSUMER DEVELOPED CHRONIC SINUS INFECTIONS AND FREQUENT HEADACHES. ON UNSPECIFIED DATES, SHE WAS SEEN BY HER PRIMARY CARE PHYSICIAN AND WAS GIVEN TREATMENT FOR THE SINUS INFECTIONS. DUE TO THE NUMBER OF INFECTIONS, SHE WAS THEN REFERRED TO AN EAR, NOSE AND THROAT (ENT)-OTOLARYNGOLOGIST WHO ADVISED A COMPUTED TOMOGRAPHY (CT) SCAN, WHICH INDICATED HER SINUS CAVITY WAS BLOCKED BY A SMALL "CYST-LIKE" MASS. SHE UNDERWENT SINUS SURGERY TO REMOVE THE MASS. DURING THE SUMMER OF 2014, A COSMETIC AND RECONSTRUCTION OCULOPLASTIC SURGEON PERFORMED A SECOND SURGERY TO REMOVE SCAR TISSUE AND LIFT THE STRETCHED SKIN UNDER HER EYES. THE CONSUMER WAS ADVISED THAT IF THE SWELLING CONTINUED, HER SKIN WOULD STRETCH AGAIN. ALL MARKET DISTRIBUTION OF THE DEVICE WAS DISCONTINUED IN 2009 AND THE MANUFACTURER (COLBAR LIFESCIENCE, LTD) HAD SUBSEQUENTLY CLOSED. A LOT NUMBER WAS NOT PROVIDED AND THE COMPLAINT INVESTIGATION WAS CLOSED WITH A DISPOSITION OF UNDETERMINED. THIS REPORT WAS ASSESSED AS SERIOUS AND COMPANY CAUSALITY WAS ASSESSED AS RELATED. ADDITIONAL INFORMATION WAS RECEIVED ON 02-MAR-2015. THE CONSUMER WAS (B)(6) AT THE ONSET OF THE EVENTS. ADDITIONAL MEDICAL HISTORY INCLUDED ALLERGIC RHINITIS, TUBAL LIGATION (1999), FOCAL ATYPICAL DUCTAL HYPERPLASIA (EXCISION ON (B)(6) 2009), MENOPAUSE, HYPERPARATHYROIDISM, TEMPOROMANDIBULAR JOINT DISORDER, ACNE VULGARIS, AND ALLERGIES TO LATEX AND MEDICAL TAPE. ADDITIONAL CONCOMITANT MEDICATIONS INCLUDED ETODOLAC, BIOIDENTICAL HORMONES, HUMIRA (ADALIMUMAB), PEPTIDE INJECTIONS, FLEXERIL (CYCLOBENZAPRINE), CELEBREX (CELECOXIB), ELOCON (MOMETASONE), AND TRAMADOL. SOCIAL HISTORY INCLUDED OCCASIONAL ALCOHOL CONSUMPTION AND PREVIOUS TOBACCO USE (0.5 PPD FOR 20 YEARS, 1998-2008). THE CONSUMER'S HEIGHT AND RECENT WEIGHT WERE (B)(6), RESPECTIVELY. THE CONSUMER WHO WAS IMMUNOSUPPRESSED HAD MULTIPLE CONSULTATIONS WITH VARIOUS PHYSICIANS SINCE 2009 FOR LOWER AND UPPER RESPIRATORY TRACT INFECTIONS INCLUDING CHRONIC SINUSITIS, ACUTE PHARYNGITIS, ASTHMATIC BRONCHITIS, LARYNGITIS, ACUTE BRONCHITIS, EUSTACHIAN TUBE DYSFUNCTION, AND ALLERGIC RHINITIS. SHE WAS TREATED WITH VARIOUS ANTIBIOTICS, STEROIDS, AND OVER THE COUNTER MEDICATIONS (CEFDINIR [(B)(6) 2009], AMOXICILLIN [(B)(6) 2010], CEFPROZIL [(B)(6) 2010], CEFDINIR AND ALBUTEROL [(B)(6) 2010], MOXIFLOXACIN [(B)(6) 2010], LEVOFLOXACIN AND MOMETASONE [(B)(6) 2011], CEFPROZIL (B)(6) 2011], MOXIFLOXACIN [(B)(6) 2011], CLARITHROMYCIN AND METHYLPREDNISOLONE [(B)(6) 2011], CEFPROZIL, METHYLPREDNISOLONE, MOMETASONE, MONTELUKAST, AZELASTINE [(B)(6) 2011], CEPHALEXIN, METHYLPREDNISOLONE, ACETAMINOPHEN/CODEINE [(B)(6) 2011], PREDNISONE [(B)(6) 2011], PREDNISONE AND CETIRIZINE [(B)(6) 2012], CEFDINIR [(B)(6) 2012], AZITHROMYCIN [(B)(6) 2014], AND CEFPROZIL [(B)(6) 2015]). TREATMENTS ALSO INCLUDING NETI POT, DIPHENHYDRAMINE, FLUTICASONE, PREDNISONE, AND CIPROFLOXACIN FOR CHRONIC MAXILLARY AND ETHMOIDAL SINUSITIS AND S-SHAPED DEVIATED NASAL SEPTUM ON (B)(6) 2011. VARIOUS DIAGNOSTICS AND SURGERIES INCLUDED A CHEST X-RAY ON (B)(6) 2010 SHOWING NO EVIDENCE OF LEFT LOWER LOBE PNEUMONIA AND SINUS X-RAY WITH NO EVIDENCE OF SINUSITIS. PARANASAL SINUSES CT ON (B)(6) 2011 INDICATED INCOMPLETE OPACIFICATION OF THE ETHMOID AND SPHENOID SINUSES. ON (B)(6) 2011, LABORATORY RESULTS WERE UNREMARKABLE WITH THE EXCEPTION OF WBC 12.5 THOUS/ML (3.8-10.8) AND NEUTROPHILS 9163 CELLS/MCL (1500-7800) AND ALLERGY PROFILE WAS POSITIVE FOR DUST MITE ALLERGY. ON (B)(6) 2011, THE CONSUMER WAS SCHEDULED FOR LIPOSUCTION. ON (B)(6) 2011, THE CONSUMER UNDERWENT BILATERAL ENDOSCOPIC BALLOON FRONTAL SINUPLASTY, ETHMOIDECTOMY, ANTROSTOMY, SEPTOPLASTY AND BILATERAL INFERIOR TURBINECTOMY. ON (B)(6) 2012, EPSTEIN-BARR VCA AB AND EBV NUCLEAR AG (EBNA) (IGG) WERE POSITIVE. ON (B)(6) 2012, SHE CONSULTED HER PRIMARY CARE PHYSICIAN DUE TO UNDER EYE SWELLING AND INTERMITTENT SWOLLEN GLANDS UNDER HER ARMS, NECK AND GROIN AND WAS DIAGNOSED WITH POSSIBLE INTERMITTENT LYMPHADENITIS AND XANTHOMAS UNDER HER EYES. ON (B)(6) 2012, AXILLARY ADENOPATHY WAS IDENTIFIED ON HER ANNUAL MEDICAL EXAM AND LABORATORY RESULTS INCLUDING WBC WERE UNREMARKABLE. ON (B)(6) 2013 MAXIOFACIAL SINUS CT RESULTS WERE NORMAL. BRAIN MAGNETIC RESONANCE IMAGING (MRI-3T) ON (B)(6) 2014 WAS PERFORMED DUE TO HISTORY OF MIGRAINES AND FACIAL INFLAMMATION AND IMPRESSION INCLUDED MINIMAL NONSPECIFIC, SUBCORTICAL AND PERIVENTRICULAR FLAIR HYPERINTENSITIES, WHICH COULD BE SEEN WITH MIGRAINE AND SMALL VESSEL ISCHEMIC CHANGE. ANOTHER MRI-3T ON (B)(6) 2014 SHOWED PINEAL REGION MASS WITH IMAGING CHARACTERISTICS MOST CONSISTENT WITH A SEPTATED PINEAL CYST. ON (B)(6) 2014 LYME DISEASE SCREENING WAS NEGATIVE. ON (B)(6) 2014, THE CONSUMER HAD A NEUROLOGICAL CONSULT AND WAS DIAGNOSED WITH MIGRAINE OR CHRONIC DAILY HEADACHE, WHICH WAS SEVERE 2-3 TIMES/WEEK AND WAS PRESCRIBED TOPIRAMATE. ON (B)(6) 2014, THE CONSUMER UNDERWENT FACIAL SURGERY AROUND EYES. ON (B)(6) 2015, THE CONSUMER UNDERWENT LS SPINE X-RAY/OBLIQUES, PELVIS X-RAY, RESULTS OF WHICH WERE NORMAL, SHE ALSO UNDERWENT SINUS CT THAT SHOWED LEFTWARD BOWING OF NASAL SEPTUM, SINOSAL ANATOMIC VARIATIONS IN THE CONFIGURATIONS OF THE DRAINAGE PATHWAYS. THIS REPORT REMAINS SERIOUS.
THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2015 FROM A (B)(6) CAUCASIAN FEMALE CONSUMER REPORTING ON SELF FROM THE UNITED STATES. MEDICAL HISTORY INCLUDED SINUS SURGERY, RHEUMATOID ARTHRITIS AND ALLERGIES TO DUST AND MOLD. SHE HAD NO KNOWN FOOD SENSITIVITIES. CONCOMITANT MEDICATIONS INCLUDED MULTIVITAMINS ONE PER DAY FOR UNSPECIFIED YEARS FOR GENERAL HEALTH AND ADVIL (IBUPROFEN) OR SOMETHING SIMILAR AS NEEDED AND PLAQUENIL (HYDROXYCHLOROQUINE) TWO PER DAY, BOTH TAKEN FOR UNSPECIFIED YEARS FOR RHEUMATOID ARTHRITIS. ON AN UNSPECIFIED DATE IN 2009, THE CONSUMER CONSULTED A FACIAL PLASTIC SURGEON. ON THE SAME NIGHT, THE PHYSICIAN INJECTED HER WITH EVOLENCE COLLAGEN FILLER (DOSE, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED) INTRADERMALLY, ONCE IN MULTIPLE LOCATIONS UNDER HER EYES FOR TREATMENT OF "HOLLOWS". DURING ADMINISTRATION, THE PHYSICIAN PRESSED DOWN AND RUBBED THE AREA. POST-INJECTION, SHE EXPERIENCED MINOR BRUISING AND SWELLING. SOON AFTER THE INJECTIONS, SHE BEGAN NOTICING LUMPS/BUMPS UNDER HER EYES. SHE WAS ALSO EXPERIENCING SIGNIFICANT SWELLING THAT LASTED FROM ONE TO THREE DAYS AND THE SWELLING RESOLVED; SHE WAS LEFT WITH BUMPS AND DROOPING, WRINKLED SKIN UNDER HER EYES. ON SEVERAL UNSPECIFIED DATES, SHE RETURNED TO THE PHYSICIAN WHO INJECTED HER WITH THE DEVICE. INITIALLY, SHE WAS ADVISED TO WAIT FOR THE SWELLING AND LUMPS TO GO DOWN AND THEN HER PHYSICIAN SUGGESTED PRESSING ON THE LUMPS. SHE WAS TREATED WITH A SERUM FROM THE PHYSICIAN'S PRODUCT LINE. THE PHYSICIAN ALSO ADVISED STEROID INJECTIONS INTO THE AFFECTED AREA IF SWOLLEN. AS RECENT AS (B)(6) 2015, THE CONSUMER WAS STILL UNDERGOING TREATMENT WITH THIS PHYSICIAN. AFTER SOME TIME, THE CONSUMER DEVELOPED CHRONIC SINUS INFECTIONS AND FREQUENT HEADACHES. ON UNSPECIFIED DATES, SHE WAS SEEN BY HER PRIMARY CARE PHYSICIAN AND WAS GIVEN TREATMENT FOR THE SINUS INFECTIONS. DUE TO THE NUMBER OF INFECTIONS, SHE WAS THEN REFERRED TO AN EAR, NOSE AND THROAT (ENT)-OTOLARYNGOLOGIST WHO ADVISED A COMPUTED TOMOGRAPHY (CT) SCAN, WHICH INDICATED HER SINUS CAVITY WAS BLOCKED BY A SMALL "CYST-LIKE" MASS. SHE UNDERWENT SINUS SURGERY TO REMOVE THE MASS. DURING THE SUMMER OF 2014, A COSMETIC AND RECONSTRUCTION OCULOPLASTIC SURGEON PERFORMED A SECOND SURGERY TO REMOVE SCAR TISSUE AND LIFT THE STRETCHED SKIN UNDER HER EYES. THE CONSUMER WAS ADVISED THAT IF THE SWELLING CONTINUED, HER SKIN WOULD STRETCH AGAIN. ALL MARKET DISTRIBUTION OF THE DEVICE WAS DISCONTINUED IN 2009 AND THE MANUFACTURER (COLBAR LIFESCIENCE, LTD) HAD SUBSEQUENTLY CLOSED. A LOT NUMBER WAS NOT PROVIDED AND THE COMPLAINT INVESTIGATION WAS CLOSED WITH A DISPOSITION OF UNDETERMINED. THIS REPORT WAS ASSESSED AS SERIOUS AND COMPANY CAUSALITY WAS ASSESSED AS RELATED. ADDITIONAL INFORMATION WAS RECEIVED ON 02-MAR-2015. THE CONSUMER WAS (B)(6) AT THE ONSET OF THE EVENTS. ADDITIONAL MEDICAL HISTORY INCLUDED ALLERGIC RHINITIS, TUBAL LIGATION (1999), FOCAL ATYPICAL DUCTAL HYPERPLASIA (EXCISION ON (B)(6)2009), MENOPAUSE, HYPERPARATHYROIDISM, TEMPOROMANDIBULAR JOINT DISORDER, ACNE VULGARIS, AND ALLERGIES TO LATEX AND MEDICAL TAPE. ADDITIONAL CONCOMITANT MEDICATIONS INCLUDED ETODOLAC, BIOIDENTICAL HORMONES, HUMIRA (ADALIMUMAB), PEPTIDE INJECTIONS, FLEXERIL (CYCLOBENZAPRINE), CELEBREX (CELECOXIB), ELOCON (MOMETASONE), AND TRAMADOL. SOCIAL HISTORY INCLUDED OCCASIONAL ALCOHOL CONSUMPTION AND PREVIOUS TOBACCO USE (0.5 PPD FOR 20 YEARS, 1998-2008). THE CONSUMER'S HEIGHT AND RECENT WEIGHT WERE (B)(6), RESPECTIVELY. THE CONSUMER WHO WAS IMMUNOSUPPRESSED HAD MULTIPLE CONSULTATIONS WITH VARIOUS PHYSICIANS SINCE 2009 FOR LOWER AND UPPER RESPIRATORY TRACT INFECTIONS INCLUDING CHRONIC SINUSITIS, ACUTE PHARYNGITIS, ASTHMATIC BRONCHITIS, LARYNGITIS, ACUTE BRONCHITIS, EUSTACHIAN TUBE DYSFUNCTION, AND ALLERGIC RHINITIS. SHE WAS TREATED WITH VARIOUS ANTIBIOTICS, STEROIDS, AND OVER THE COUNTER MEDICATIONS (CEFDINIR [(B)(6) 2009], AMOXICILLIN [(B)(6) 2010], CEFPROZIL [(B)(6) 2010], CEFDINIR AND ALBUTEROL [(B)(6) 2010], MOXIFLOXACIN [(B)(6) 2010], LEVOFLOXACIN AND MOMETASONE [(B)(6) 2011], CEFPROZIL [(B)(6) 2011], MOXIFLOXACIN [(B)(6) 2011], CLARITHROMYCIN AND METHYLPREDNISOLONE [(B)(6) 2011], CEFPROZIL, METHYLPREDNISOLONE, MOMETASONE, MONTELUKAST, AZELASTINE [(B)(6) 2011], CEPHALEXIN, METHYLPREDNISOLONE, ACETAMINOPHEN/CODEINE [(B)(6) 2011], PREDNISONE [(B)(6) 2011], PREDNISONE AND CETIRIZINE [(B)(6) 2012], CEFDINIR [(B)(6) 2012], AZITHROMYCIN [(B)(6) 2014], AND CEFPROZIL [(B)(6) 2015]). TREATMENTS ALSO INCLUDING NETI POT, DIPHENHYDRAMINE, FLUTICASONE, PREDNISONE, AND CIPROFLOXACIN FOR CHRONIC MAXILLARY AND ETHMOIDAL SINUSITIS AND S-SHAPED DEVIATED NASAL SEPTUM ON (B)(6) 2011. VARIOUS DIAGNOSTICS AND SURGERIES INCLUDED A CHEST X-RAY ON (B)(6) 2010 SHOWING NO EVIDENCE OF LEFT LOWER LOBE PNEUMONIA AND SINUS X-RAY WITH NO EVIDENCE OF SINUSITIS. PARANASAL SINUSES CT ON (B)(6) 2011 INDICATED INCOMPLETE OPACIFICATION OF THE ETHMOID AND SPHENOID SINUSES. ON (B)(6) 2011, LABORATORY RESULTS WERE UNREMARKABLE WITH THE EXCEPTION OF WBC 12.5 THOUS/ML (3.8-10.8) AND NEUTROPHILS 9163 CELLS/MCL (1500-7800) AND ALLERGY PROFILE WAS POSITIVE FOR DUST MITE ALLERGY. ON (B)(6) 2011, THE CONSUMER WAS SCHEDULED FOR LIPOSUCTION. ON (B)(6) 2011, THE CONSUMER UNDERWENT BILATERAL ENDOSCOPIC BALLOON FRONTAL SINUPLASTY, ETHMOIDECTOMY, ANTROSTOMY, SEPTOPLASTY AND BILATERAL INFERIOR TURBINECTOMY. ON (B)(6) 2012, EPSTEIN-BARR VCA AB AND EBV NUCLEAR AG (EBNA) (IGG) WERE POSITIVE. ON (B)(6) 2012, SHE CONSULTED HER PRIMARY CARE PHYSICIAN DUE TO UNDER EYE SWELLING AND INTERMITTENT SWOLLEN GLANDS UNDER HER ARMS, NECK AND GROIN AND WAS DIAGNOSED WITH POSSIBLE INTERMITTENT LYMPHADENITIS AND XANTHOMAS UNDER HER EYES. ON (B)(6) 2012, AXILLARY ADENOPATHY WAS IDENTIFIED ON HER ANNUAL MEDICAL EXAM AND LABORATORY RESULTS INCLUDING WBC WERE UNREMARKABLE. ON (B)(6) 2013 MAXIOFACIAL SINUS CT RESULTS WERE NORMAL. BRAIN MAGNETIC RESONANCE IMAGING (MRI-3T) ON (B)(6) 2014 WAS PERFORMED DUE TO HISTORY OF MIGRAINES AND FACIAL INFLAMMATION AND IMPRESSION INCLUDED MINIMAL NONSPECIFIC, SUBCORTICAL AND PERIVENTRICULAR FLAIR HYPERINTENSITIES, WHICH COULD BE SEEN WITH MIGRAINE AND SMALL VESSEL ISCHEMIC CHANGE. ANOTHER MRI-3T ON (B)(6) 2014 SHOWED PINEAL REGION MASS WITH IMAGING CHARACTERISTICS MOST CONSISTENT WITH A SEPTATED PINEAL CYST. ON (B)(6) 2014 LYME DISEASE SCREENING WAS NEGATIVE. ON (B)(6) 2014, THE CONSUMER HAD A NEUROLOGICAL CONSULT AND WAS DIAGNOSED WITH MIGRAINE OR CHRONIC DAILY HEADACHE, WHICH WAS SEVERE 2-3 TIMES/WEEK AND WAS PRESCRIBED TOPIRAMATE. ON (B)(6) 2014, THE CONSUMER UNDERWENT FACIAL SURGERY AROUND EYES. ON (B)(6) 2015, THE CONSUMER UNDERWENT LS SPINE X-RAY/OBLIQUES, PELVIS X-RAY, RESULTS OF WHICH WERE NORMAL, SHE ALSO UNDERWENT SINUS CT THAT SHOWED LEFTWARD BOWING OF NASAL SEPTUM, SINOSAL ANATOMIC VARIATIONS IN THE CONFIGURATIONS OF THE DRAINAGE PATHWAYS. THIS REPORT REMAINS SERIOUS. ADDITIONAL INFORMATION WAS RECEIVED ON 27-MAR-2015. ADDITIONAL MEDICAL HISTORY INCLUDED VIRAL MENINGITIS (1986), INSOMNIA, DRY EYE SYNDROME, ROSACEA, ABNORMAL BLEEDING TENDENCY AND EASY BRUISING AND SINUS INFECTIONS ON OCCASION. COSMETIC PROCEDURES INCLUDED BOTOX IN HER FOREHEAD AND MICRODERMABRASION (2004), FACIAL DERMAL FILLERS, AND LASER HAIR REMOVAL ((B)(6) 2009). ADDITIONAL ALLERGIES INCLUDED STRAWBERRIES, ENVIRONMENTAL, SEASONAL, AND UNSPECIFIED FOOD ALLERGIES. ADDITIONAL CONCOMITANT MEDICATIONS INCLUDED RESTASIS (CYCLOSPORINE), RETIN-A (TRETINOIN), NORITATE (METRONIDAZOLE), CALCIUM, VITAMIN D, AND SEQUOIA, RUBES AND RIBES EXTRACTS. ON (B)(6) 2009, THE CONSUMER WAS INJECTED WITH EVOLENCE COLLAGEN FILLER. FOLLOWING ADMINISTRATION, THE CONSUMER HAD NUMEROUS CONSULTATIONS WITH THE SAME PHYSICIAN BECAUSE OF THE BUMPS/LUMPS SHE DEVELOPED UNDER HER EYES. UPON FOLLOW-UP ON (B)(6) 2010, FILLER DEPOSITS WERE VISIBLE IN THE MID RIGHT ORBITAL RIM AND MID AND LEFT LATERAL ORBITAL RIM AND KENNALOG (TRIAMCINOLONE) 0.2 MILLILITERS WAS INJECTED INTO THE THREE DEPOSITS. ON (B)(6) 2010, EXAMINATION REVEALED NO VISIBLE OR PALPABLE DEPOSITS AND THE SAME PHYSICIAN DISCUSSED RESTYLANE (NON-ANIMAL STABILIZED HYALURONIC ACID) INTO THE PERIORBITAL . ON (B)(6) 2011, THE PHYSICIAN ASSESSED THE LATERAL ORBITAL RIM RIGHT TWO DEPOSITS WERE TWO MM IN SIZE AND DIMINISHED GREATLY FROM PRIOR CONSULT. ON (B)(6) 2013, THE CONSUMER CONSULTED THE SAME PHYSICIAN REGARDING THE EXCESS SKIN UNDER HER EYES DUE TO INTERMITTENT STRETCHING AND SWELLING, WHICH WAS ASSESSED AS INTERMITTENT LYMPHATIC EDEMA. ON (B)(6) 2014, SHE CONSULTED WITH A COSMETIC AND RECONSTRUCTIVE EYE AND FACIAL PLASTIC SURGEON DUE TO UNDER HER EYES WERE SWELLING UNDER HER EYES WITH THROBBING PAIN AND PERIPHERAL VISUAL ACUITY LOSS FOR ONE TO TWO YEARS AND WAS DIAGNOSED WITH DERMATOCHALASIS. VISUAL ACUITY WAS 20/20 FOR BOTH EYES. ON (B)(6) 2014, SHE UNDERWENT COSMETIC BLEPHAROPLASTY OF LOWER EYELIDS. SHE HAD OTHER REGULAR CONSULTATIONS WITH A RHEUMATOLOGIST AND AN ALLERGIST, WHO RECOMMENDED ADDING ANTI-INFLAMMATORY DRUGS AND ANTI-DEPRESSANTS SUCH AS CYMBALTA (DULOXETINE) AND FLEXERIL (CYCLOBENZAPRINE), AND CONTINUING UNSPECIFIED ALLERGY SHOTS AND ALLERGY MEDICINE, RESPECTIVELY. THIS REPORT REMAINS SERIOUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 127843 | EVOLENCE COLLAGEN FILLER | IMPLANT, DERMAL, FOR AESTHETIC USE | LMH | COLBAR LIFESCIENCE, LTD | EVOLENUS | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Required Intervention | ADVIL| MULTI-VITAMIN| PLAQUENIL |