ESSURE
Report
- Report Number
- 2951250-2018-02056
- Event Type
- Injury
- Date Received
- May 4, 2018
- Date of Event
- January 1, 2014
- Report Date
- July 8, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND MAST CELL ACTIVATION SYNDROME ("MAST CELL ACTIVATION DISORDER") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MAST CELL ACTIVATION SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ALOPECIA ("HAIR LOSS"), MIGRAINE ("MIGRAINES") AND DYSPAREUNIA ("PAINFUL INTERCOURSE"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE IMPLANT REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MAST CELL ACTIVATION SYNDROME, ALOPECIA, MIGRAINE AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, DYSPAREUNIA, MAST CELL ACTIVATION SYNDROME, MIGRAINE AND PELVIC PAIN TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-JUN-2018: QUALITY SAFETY EVALUATION OF PTC. INCIDENT: NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN'), MAST CELL ACTIVATION SYNDROME ('MAST CELL ACTIVATION DISORDER') AND ENDOMETRIOSIS ABLATION ('EXCISION') IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B21581) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OVERWEIGHT, HYPERTENSION, BACTERIAL VAGINOSIS, ADHD, FIBROMYALGIA, ASTHMA CHRONIC, VOCAL CORD DYSFUNCTION, EHLERS-DANLOS SYNDROME, LEFT LOWER QUADRANT PAIN, MENSTRUAL DISORDER, CYSTITIS INTERSTITIAL, MOOD ALTERED, HYPERTENSION, URINARY FREQUENCY, LEIOMYOMA NOS AND PAIN IN HIP. GROSS DESCRIPTION: RESULT. A. THE SPECIMEN IS RECEIVED FIXED IN FORMALIN IN ONE CONTAINER, LABELED WIT THE PATIENT'S WITH CERVIX AND BILATERAL FALLOPIAN TUBE" AND CONSISTS OF AN ALREADY BIVALVE:1 UTERUS MEASURING 8.2 CM X 7.4 CM X 6 2 CM PINK-TAN UTERUS. THE SEROSAL SURFACE IS SMOOTH AND GLISTENING AND PIRK-TAN. THE BIVALVE UTERUS SHOWS MULTIPLE YELLOW-TAN CIRCUMSCRIBED NODULES RANGING FROM 1.4 TOIL 3 CM IN GREATEST DIMENSION. THE ENTIRE SPECIMEN WEIGHS 69.9 GRAMS. THERE ARE HIE FALLOPIAN TUBES ATTACHED TO THE SPECIMEN. THE RIGHT 'RATIO-PLAN TUBE MEASURES 10.2 IX 0.5 URN AND THE LEFT FALLOPIAN TUBE MEASURES. 8.6 X 0 5 CM. THE ARE METAL STRINGS IN BOTH FALLOPIAN TUBES. REPRESENTATIVE SECTIONS ARE SUBMITTED AS FOLLOWS:. AL - ANTERIOR CERVIX. A2 - POSTERIOR CERVIX. A3 - ANTERIOR UTERUS WITH NODULE. A3 - ANTERIOR UTERUS WITH NODULE. A4- POSTERIOR UTERUS WITH NODULE. A5- NIGHT FALLOPIAN TUBE. A6 - LEFT FALLOPIAN TUBE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: CAMILA AND NUVARING. CONCOMITANT PRODUCTS INCLUDED AMFETAMINE ASPARTATE;AMFETAMINE SULFATE;DEXAMFETAMINE SACCHARATE;DEXAMFETAMINE SULFATE (ADDERALL), AZELASTINE HYDROCHLORIDE, BORIC ACID PRODUCTS, BOTULINUM TOXIN TYPE A (BOTOX), CETIRIZINE HYDROCHLORIDE, CLOBETASOL, ESTRADIOL (ESTROGEN), ESTROGENS CONJUGATED (PREMARIN), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), GLUCOSAMINE SULFATE (FLEXTRIL), INDOMETACIN, LISINOPRIL, LISINOPRIL (ZESTRIL), METOPROLOL, MOMETASONE FUROATE (ASMANEX), MONTELUKAST, ONDANSETRON HYDROCHLORIDE, PHENAZOPYRIDINE HYDROCHLORIDE (PYRIDIUM), PROPRANOLOL, RANITIDINE, SALBUTAMOL SULFATE (ALBUTEROL SULFATE), SUMATRIPTAN, TOPIRAMATE, TOPIRAMATE AND TRAZODONE. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALOPECIA ("HAIR LOSS"), MIGRAINE ("MIGRAINES"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL/CLOT"), MENORRHAGIA ("MENORRHAGIA / CLOTS"), HYPERSENSITIVITY ("HYPERSENSITIVITY"), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME ("POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME / POTS"), MOOD SWINGS ("MOOD SWINGS"), HEADACHE ("HEADACHES / HEAD PAIN"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE") AND VISION BLURRED ("BLURRY VISION"). IN (B)(6) 2015, THE PATIENT EXPERIENCED DIARRHOEA ("DIARRHEA") AND CONSTIPATION ("CONSTIPATION"). IN 2015, THE PATIENT EXPERIENCED IRRITABLE BOWEL SYNDROME ("IBS"). IN (B)(6) 2015, THE PATIENT EXPERIENCED PHOTOPHOBIA ("LIGHT SENSITIVITY"). IN (B)(6) 2016, THE PATIENT EXPERIENCED CYSTITIS INTERSTITIAL ("BLADDER OR URINARY PROBLEMS OR CHANGES : CYSTITIS INTERSTITIAL"). IN 2017, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN."). ON AN UNKNOWN DATE, THE PATIENT UNDERWENT ENDOMETRIOSIS ABLATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 4 YEARS 5 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MAST CELL ACTIVATION SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), NECK PAIN ("HEAD NECK PAIN"), BACK PAIN ("LOW BACK PAIN"), ARTHRALGIA ("JOINT PAIN/HIP PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND APHASIA ("APHASIA") AND UNDERWENT BLADDER HYDRODISTENSION ("CYSTOSCOPY/HYDRO DISTENSION"). THE PATIENT WAS TREATED WITH SURGERY (EXCISION AND HYSTERECTOMY/SALPINGECTOMY (BILATERAL) AND UTEROSACRAL LIGAMENT SUSPENSION). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSPAREUNIA AND ARTHRALGIA WAS RESOLVING, THE MAST CELL ACTIVATION SYNDROME, ENDOMETRIOSIS ABLATION, MIGRAINE, VAGINAL HAEMORRHAGE, MENORRHAGIA, HYPERSENSITIVITY, CYSTITIS INTERSTITIAL, POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME, MOOD SWINGS, HEADACHE, NAUSEA, ALLERGY TO METALS, DYSMENORRHOEA, FATIGUE, IRRITABLE BOWEL SYNDROME, BLADDER HYDRODISTENSION, VISION BLURRED, WEIGHT INCREASED, NECK PAIN, BACK PAIN, ABDOMINAL PAIN, PHOTOPHOBIA, DIARRHOEA, CONSTIPATION AND APHASIA OUTCOME WAS UNKNOWN AND THE ALOPECIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, APHASIA, ARTHRALGIA, BACK PAIN, BLADDER HYDRODISTENSION, CONSTIPATION, CYSTITIS INTERSTITIAL, DIARRHOEA, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS ABLATION, FATIGUE, HEADACHE, HYPERSENSITIVITY, IRRITABLE BOWEL SYNDROME, MAST CELL ACTIVATION SYNDROME, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, NECK PAIN, PELVIC PAIN, PHOTOPHOBIA, POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME, VAGINAL HAEMORRHAGE, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: COILS SHOWING RIGHT SIDE 1, LEFT SIDE 1. LEGACY DEVICE REPORT NUM 2951250-2020-06031 MEDWATCH 3500A MFR NUMBER. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULT: THE LEFT TUBE CLOSED, NOT THE RIGHT; ON (B)(6) 2014: TOTAL BILATERAL OCCLUSION. CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS: DYSPAREUNIA, LOWER BACK PAIN, PELVIC PAIN, MENORRHAGIA, HEADACHE, MIGRAINES, ABDOMINAL PAIN, JOINT PAIN, DYSMENORRHEA, ENDOMETRIOSIS, UTEROSACRAL LIGAMENT SUSPENSION AND BACTERIAL VAGINOSIS CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONES WERE DESCRIBED VIA SOCIAL MEDIA: CLOTS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-JUN-2020: QUALITY SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN'), MAST CELL ACTIVATION SYNDROME ('MAST CELL ACTIVATION DISORDER') AND ENDOMETRIOSIS ABLATION ('EXCISION') IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B21581) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OVERWEIGHT, HYPERTENSION, BACTERIAL VAGINOSIS, ADHD, FIBROMYALGIA, ASTHMA CHRONIC, VOCAL CORD DYSFUNCTION, EHLERS-DANLOS SYNDROME, LEFT LOWER QUADRANT PAIN, MENSTRUAL DISORDER, CYSTITIS INTERSTITIAL, MOOD ALTERED, HYPERTENSION, URINARY FREQUENCY, LEIOMYOMA NOS AND PAIN IN HIP. GROSS DESCRIPTION: RESULT. A. THE SPECIMEN IS RECEIVED FIXED IN FORMALIN IN ONE CONTAINER, LABELED WIT THE PATIENT'S WITH CERVIX AND BILATERAL FALLOPIAN TUBE" AND CONSISTS OF AN ALREADY BIVALVE:1 UTERUS MEASURING 8.2 CM X 7.4 CM X 6 2 CM PINK-TAN UTERUS. THE SEROSAL SURFACE IS SMOOTH AND GLISTENING AND PIRK-TAN. THE BIVALVE UTERUS SHOWS MULTIPLE YELLOW-TAN CIRCUMSCRIBED NODULES RANGING FROM 1.4 TOIL 3 CM IN GREATEST DIMENSION. THE ENTIRE SPECIMEN WEIGHS 69.9 GRAMS. THERE ARE HIE FALLOPIAN TUBES ATTACHED TO THE SPECIMEN. THE RIGHT 'RATIO-PLAN TUBE MEASURES 10.2 IX 0.5 URN AND THE LEFT FALLOPIAN TUBE MEASURES. 8.6 X 0 5 CM. THE ARE METAL STRINGS IN BOTH FALLOPIAN TUBES. REPRESENTATIVE SECTIONS ARE SUBMITTED AS FOLLOWS:. AL - ANTERIOR CERVIX. A2 - POSTERIOR CERVIX. A3 - ANTERIOR UTERUS WITH NODULE. A3 - ANTERIOR UTERUS WITH NODULE. A4- POSTERIOR UTERUS WITH NODULE. A5- NIGHT FALLOPIAN TUBE. A6 - LEFT FALLOPIAN TUBE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: CAMILA AND NUVARING. CONCOMITANT PRODUCTS INCLUDED (), AMFETAMINE ASPARTATE;AMFETAMINE SULFATE;DEXAMFETAMINE SACCHARATE;DEXAMFETAMINE SULFATE (ADDERALL), AZELASTINE HYDROCHLORIDE, BORIC ACID PRODUCTS, BOTULINUM TOXIN TYPE A (BOTOX), CETIRIZINE HYDROCHLORIDE, CLOBETASOL, ESTRADIOL (ESTROGEN), ESTROGENS CONJUGATED (PREMARIN), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), GLUCOSAMINE SULFATE (FLEXTRIL), INDOMETACIN, LISINOPRIL, LISINOPRIL (ZESTRIL), METOPROLOL, MOMETASONE FUROATE (ASMANEX), MONTELUKAST, ONDANSETRON HYDROCHLORIDE, PHENAZOPYRIDINE HYDROCHLORIDE (PYRIDIUM), PROPRANOLOL, RANITIDINE, SALBUTAMOL SULFATE (ALBUTEROL SULFATE), SUMATRIPTAN, TOPIRAMATE, TOPIRAMATE AND TRAZODONE. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALOPECIA ("HAIR LOSS"), MIGRAINE ("MIGRAINES"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL/CLOT"), MENORRHAGIA ("MENORRHAGIA / CLOTS"), HYPERSENSITIVITY ("HYPERSENSITIVITY"), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME ("POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME / POTS"), MOOD SWINGS ("MOOD SWINGS"), HEADACHE ("HEADACHES / HEAD PAIN"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE") AND VISION BLURRED ("BLURRY VISION"). IN (B)(6) 2015, THE PATIENT EXPERIENCED DIARRHOEA ("DIARRHEA") AND CONSTIPATION ("CONSTIPATION"). IN 2015, THE PATIENT EXPERIENCED IRRITABLE BOWEL SYNDROME ("IBS"). IN (B)(6) 2015, THE PATIENT EXPERIENCED PHOTOPHOBIA ("LIGHT SENSITIVITY"). IN (B)(6) 2016, THE PATIENT EXPERIENCED CYSTITIS INTERSTITIAL ("BLADDER OR URINARY PROBLEMS OR CHANGES : CYSTITIS INTERSTITIAL"). IN 2017, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN."). ON AN UNKNOWN DATE, THE PATIENT UNDERWENT ENDOMETRIOSIS ABLATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 4 YEARS 5 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MAST CELL ACTIVATION SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), NECK PAIN ("HEAD NECK PAIN"), BACK PAIN ("LOW BACK PAIN"), ARTHRALGIA ("JOINT PAIN/HIP PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND APHASIA ("APHASIA") AND UNDERWENT BLADDER HYDRODISTENSION ("CYSTOSCOPY/HYDRO DISTENSION"). THE PATIENT WAS TREATED WITH SURGERY (EXCISION AND HYSTERECTOMY/SALPINGECTOMY (BILATERAL) AND UTEROSACRAL LIGAMENT SUSPENSION). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSPAREUNIA AND ARTHRALGIA WAS RESOLVING, THE MAST CELL ACTIVATION SYNDROME, ENDOMETRIOSIS ABLATION, MIGRAINE, VAGINAL HAEMORRHAGE, MENORRHAGIA, HYPERSENSITIVITY, CYSTITIS INTERSTITIAL, POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME, MOOD SWINGS, HEADACHE, NAUSEA, ALLERGY TO METALS, DYSMENORRHOEA, FATIGUE, IRRITABLE BOWEL SYNDROME, BLADDER HYDRODISTENSION, VISION BLURRED, WEIGHT INCREASED, NECK PAIN, BACK PAIN, ABDOMINAL PAIN, PHOTOPHOBIA, DIARRHOEA, CONSTIPATION AND APHASIA OUTCOME WAS UNKNOWN AND THE ALOPECIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, APHASIA, ARTHRALGIA, BACK PAIN, BLADDER HYDRODISTENSION, CONSTIPATION, CYSTITIS INTERSTITIAL, DIARRHOEA, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS ABLATION, FATIGUE, HEADACHE, HYPERSENSITIVITY, IRRITABLE BOWEL SYNDROME, MAST CELL ACTIVATION SYNDROME, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, NECK PAIN, PELVIC PAIN, PHOTOPHOBIA, POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME, VAGINAL HAEMORRHAGE, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: COILS SHOWING RIGHT SIDE 1, LEFT SIDE 1. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULT: THE LEFT TUBE CLOSED, NOT THE RIGHT; ON (B)(6) 2014: TOTAL BILATERAL OCCLUSION. CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS: DYSPAREUNIA, LOWER BACK PAIN, PELVIC PAIN, MENORRHAGIA, HEADACHE, MIGRAINES, ABDOMINAL PAIN, JOINT PAIN, DYSMENORRHEA, ENDOMETRIOSIS, UTEROSACRAL LIGAMENT SUSPENSION AND BACTERIAL VAGINOSIS CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONES WERE DESCRIBED VIA SOCIAL MEDIA: CLOTS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-DEC-2019: PLAINTIFF FACT SHEET AND SOCIAL MEDIA CONTENT RECEIVED: EVENT APHASIA WAS ADDED FROM SOCIAL MEDIA. INCIDENT: WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), MAST CELL ACTIVATION SYNDROME ("MAST CELL ACTIVATION DISORDER") AND ENDOMETRIOSIS ABLATION ("EXCISION") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B21581) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OVERWEIGHT, HYPERTENSION, BACTERIAL VAGINOSIS, ADHD, FIBROMYALGIA, ASTHMA CHRONIC, VOCAL CORD DYSFUNCTION, EHLERS-DANLOS SYNDROME, LEFT LOWER QUADRANT PAIN, MENSTRUAL DISORDER, CYSTITIS INTERSTITIAL, MOOD ALTERED, HYPERTENSION, URINARY FREQUENCY, LEIOMYOMA NOS AND PAIN IN HIP. GROSS DESCRIPTION: RESULT. A. THE SPECIMEN IS RECEIVED FIXED IN FORMALIN IN ONE CONTAINER, LABELED WIT THE PATIENT'S WITH CERVIX AND BILATERAL FALLOPIAN TUBE" AND CONSISTS OF AN ALREADY BIVALVE:1 UTERUS MEASURING 8.2 CM X 7.4 CM X 6 2 CM PINK-TAN UTERUS. THE SEROSAL SURFACE IS SMOOTH AND GLISTENING AND PIRK-TAN. THE BIVALVE UTERUS SHOWS MULTIPLE YELLOW-TAN CIRCUMSCRIBED NODULES RANGING FROM 1.4 TOIL 3 CM IN GREATEST DIMENSION. THE ENTIRE SPECIMEN WEIGHS 69.9 GRAMS. THERE ARE HIE FALLOPIAN TUBES ATTACHED TO THE SPECIMEN. THE RIGHT 'RATIO-PLAN TUBE MEASURES 10.2 IX 0.5 URN AND THE LEFT FALLOPIAN TUBE MEASURES. 8.6 X 0 5 CM. THE ARE METAL STRINGS IN BOTH FALLOPIAN TUBES. REPRESENTATIVE SECTIONS ARE SUBMITTED AS FOLLOWS:. AL - ANTERIOR CERVIX. A2 - POSTERIOR CERVIX. A3 - ANTERIOR UTERUS WITH NODULE. A3 - ANTERIOR UTERUS WITH NODULE. A4- POSTERIOR UTERUS WITH NODULE. A5- NIGHT FALLOPIAN TUBE. A6 - LEFT FALLOPIAN TUBE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: CAMILA AND NUVARING. CONCOMITANT PRODUCTS INCLUDED AMFETAMINE ASPARTATE;AMFETAMINE SULFATE;DEXAMFETAMINE SACCHARATE;DEXAMFETAMINE SULFATE (ADDERALL), AZELASTINE HYDROCHLORIDE, BORIC ACID PRODUCTS, BOTULINUM TOXIN TYPE A (BOTOX), CETIRIZINE HYDROCHLORIDE, CLOBETASOL, ERENUMAB AOOE (AIMOVIG), ESTRADIOL (ESTROGEN), ESTROGENS CONJUGATED (PREMARIN), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), GLUCOSAMINE SULFATE (FLEXTRIL), INDOMETACIN, LISINOPRIL, LISINOPRIL (ZESTRIL), METOPROLOL, MOMETASONE FUROATE (ASMANEX), MONTELUKAST, ONDANSETRON HYDROCHLORIDE, PHENAZOPYRIDINE HYDROCHLORIDE (PYRIDIUM), PROPRANOLOL, RANITIDINE, SALBUTAMOL SULFATE (ALBUTEROL SULFATE), SUMATRIPTAN, TOPIRAMATE, TOPIRAMATE AND TRAZODONE. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALOPECIA ("HAIR LOSS"), MIGRAINE ("MIGRAINES"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL"), MENORRHAGIA ("MENORRHAGIA"), HYPERSENSITIVITY ("HYPERSENSITIVITY"), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME ("POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME"), MOOD SWINGS ("MOOD SWINGS"), HEADACHE ("HEADACHES / HEAD PAIN"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE") AND VISION BLURRED ("BLURRY VISION"). IN 2015, THE PATIENT EXPERIENCED IRRITABLE BOWEL SYNDROME ("IBS"). IN 2017, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN."). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MAST CELL ACTIVATION SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BLADDER DISORDER ("BLADDER DISORDER"), URINARY TRACT DISORDER ("URINARY TRACT DISORDER"), NECK PAIN ("HEAD NECK PAIN"), BACK PAIN ("LOW BACK PAIN"), ARTHRALGIA ("JOINT PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN") AND UNDERWENT ENDOMETRIOSIS ABLATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND BLADDER HYDRODISTENSION ("CYSTOSCOPY/HYDRO DISTENSION"). THE PATIENT WAS TREATED WITH SURGERY (EXCISION AND HYSTERECTOMY/SALPINGECTOMY (BILATERAL) AND UTEROSACRAL LIGAMENT SUSPENSION) AND UROSACRAL LIGAMENT SUSPENSION. ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSPAREUNIA AND ARTHRALGIA WAS RESOLVING, THE MAST CELL ACTIVATION SYNDROME, ENDOMETRIOSIS ABLATION, MIGRAINE, VAGINAL HAEMORRHAGE, MENORRHAGIA, HYPERSENSITIVITY, BLADDER DISORDER, URINARY TRACT DISORDER, POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME, MOOD SWINGS, HEADACHE, NAUSEA, ALLERGY TO METALS, DYSMENORRHOEA, FATIGUE, IRRITABLE BOWEL SYNDROME, BLADDER HYDRODISTENSION, VISION BLURRED, WEIGHT INCREASED, NECK PAIN, BACK PAIN AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN AND THE ALOPECIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, ARTHRALGIA, BACK PAIN, BLADDER DISORDER, BLADDER HYDRODISTENSION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS ABLATION, FATIGUE, HEADACHE, HYPERSENSITIVITY, IRRITABLE BOWEL SYNDROME, MAST CELL ACTIVATION SYNDROME, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, NECK PAIN, PELVIC PAIN, POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: COILS SHOWING RIGHT SIDE 1, LEFT SIDE 1. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULT: THE LEFT TUBE CLOSED, NOT THE RIGHT; ON (B)(6) 2014: TOTAL BILATERAL OCCLUSION. CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS: DYSPAREUNIA, LOWER BACK PAIN, PELVIC PAIN, MENORRHAGIA, HEADACHE, MIGRAINES, ABDOMINAL PAIN, JOINT PAIN, DYSMENORRHEA, ENDOMETRIOSIS, UTEROSACRAL LIGAMENT SUSPENSION AND BACTERIAL VAGINOSIS QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-APR-2019: QUALITY SAFETY EVALUATION OF PTC. INCIDENT WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), MAST CELL ACTIVATION SYNDROME ("MAST CELL ACTIVATION DISORDER") AND ENDOMETRIOSIS ("EXCISION") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B21581) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OVERWEIGHT, HYPERTENSION, BACTERIAL VAGINOSIS, ADHD, FIBROMYALGIA, ASTHMA, VOCAL CORD DYSFUNCTION, EHLERS-DANLOS SYNDROME, LEFT LOWER QUADRANT PAIN, PERIODONTAL DISEASE, CYSTITIS INTERSTITIAL, MOOD ALTERED, HYPERTENSION, URINARY FREQUENCY, LEIOMYOMA AND PAIN IN HIP. GROSS DESCRIPTION: RESULT. A. THE SPECIMEN IS RECEIVED FIXED IN FORMALIN IN ONE CONTAINER, LABELED WIT THE PATIENT'S WITH CERVIX AND BILATERAL FALLOPIAN TUBE" AND CONSISTS OF AN ALREADY BIVALVE:1 UTERUS MEASURING 8.2 CM X 7.4 CM X 6 2 CM PINK-TAN UTERUS. THE SEROSAL SURFACE IS SMOOTH AND GLISTENING AND PIRK-TAN. THE BIVALVE UTERUS SHOWS MULTIPLE YELLOW-TAN CIRCUMSCRIBED NODULES RANGING FROM 1.4 TOIL 3 CM IN GREATEST DIMENSION. THE ENTIRE SPECIMEN WEIGHS 69.9 GRAMS. THERE ARE HIE FALLOPIAN TUBES ATTACHED TO THE SPECIMEN. THE RIGHT 'RATIO-PLAN TUBE MEASURES 10.2 IX 0.5 URN AND THE LEFT FALLOPIAN TUBE MEASURES. 8.6 X 0 5 CM. THE ARE METAL STRINGS IN BOTH FALLOPIAN TUBES. REPRESENTATIVE SECTIONS ARE SUBMITTED AS FOLLOWS:. AL - ANTERIOR CERVIX. A2 - POSTERIOR CERVIX. A3 - ANTERIOR UTERUS WITH NODULE. A3 - ANTERIOR UTERUS WITH NODULE. A4- POSTERIOR UTERUS WITH NODULE. A5- NIGHT FALLOPIAN TUBE. A6 - LEFT FALLOPIAN TUBE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: CAMILA AND NUVARING. CONCOMITANT PRODUCTS INCLUDED AMFETAMINE ASPARTATE;AMFETAMINE SULFATE;DEXAMFETAMINE SACCHARATE;DEXAMFETAMINE SULFATE (ADDERALL), AZELASTINE HYDROCHLORIDE, BORIC ACID PRODUCTS, BOTULINUM TOXIN TYPE A (BOTOX), CETIRIZINE HYDROCHLORIDE, CLOBETASOL, ERENUMAB AOOE (AIMOVIG), ESTRADIOL (ESTROGEN), ESTROGENS CONJUGATED (PREMARIN), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), GLUCOSAMINE SULFATE (FLEXTRIL), INDOMETACIN, LISINOPRIL, LISINOPRIL (ZESTRIL), METOPROLOL, MOMETASONE FUROATE (ASMANEX), MONTELUKAST, ONDANSETRON HYDROCHLORIDE, PHENAZOPYRIDINE HYDROCHLORIDE (PYRIDIUM), PROPRANOLOL, RANITIDINE, SALBUTAMOL SULFATE (ALBUTEROL SULFATE), SUMATRIPTAN, TOPIRAMATE, TOPIRAMATE AND TRAZODONE. ON (B)(6)2013, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALOPECIA ("HAIR LOSS"), MIGRAINE ("MIGRAINES"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL"), MENORRHAGIA ("MENORRHAGIA"), HYPERSENSITIVITY ("HYPERSENSITIVITY"), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME ("POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME"), MOOD SWINGS ("MOOD SWINGS"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE") AND VISION BLURRED ("BLURRY VISION"). IN 2015, THE PATIENT EXPERIENCED IRRITABLE BOWEL SYNDROME ("IBS"). IN 2017, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN."). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MAST CELL ACTIVATION SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ENDOMETRIOSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BLADDER DISORDER ("BLADDER DISORDER"), URINARY TRACT DISORDER ("URINARY TRACT DISORDER"), NECK PAIN ("HEAD NECK PAIN"), BACK PAIN ("LOW BACK PAIN"), ARTHRALGIA ("JOINT PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN") AND UNDERWENT BLADDER HYDRODISTENSION ("CYSTOSCOPY/HYDRO DISTENSION"). THE PATIENT WAS TREATED WITH SURGERY (EXCISION AND HYSTERECTOMY/SALPINGECTOMY (BILATERAL) AND UTEROSACRAL LIGAMENT SUSPENSION) AND UROSACRAL LIGAMENT SUSPENSION. ESSURE WAS REMOVED ON (B)(6)2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSPAREUNIA AND ARTHRALGIA WAS RESOLVING, THE MAST CELL ACTIVATION SYNDROME, ENDOMETRIOSIS, MIGRAINE, VAGINAL HAEMORRHAGE, MENORRHAGIA, HYPERSENSITIVITY, BLADDER DISORDER, URINARY TRACT DISORDER, POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME, MOOD SWINGS, HEADACHE, NAUSEA, ALLERGY TO METALS, DYSMENORRHOEA, FATIGUE, IRRITABLE BOWEL SYNDROME, BLADDER HYDRODISTENSION, VISION BLURRED, WEIGHT INCREASED, NECK PAIN, BACK PAIN AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN AND THE ALOPECIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, ARTHRALGIA, BACK PAIN, BLADDER DISORDER, BLADDER HYDRODISTENSION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FATIGUE, HEADACHE, HYPERSENSITIVITY, IRRITABLE BOWEL SYNDROME, MAST CELL ACTIVATION SYNDROME, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, NECK PAIN, PELVIC PAIN, POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: COILS SHOWING RIGHT SIDE 1, LEFT SIDE 1. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6)2013: RESULT: THE LEFT TUBE CLOSED, NOT THE RIGHT; ON (B)(6)2014: TOTAL BILATERAL OCCLUSION. CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS: DYSPAREUNIA, LOWER BACK PAIN, PELVIC PAIN, MENORRHAGIA, HEADACHE, MIGRAINES, ABDOMINAL PAIN, JOINT PAIN, DYSMENORRHEA, ENDOMETRIOSIS, UTEROSACRAL LIGAMENT SUSPENSION AND BACTERIAL VAGINOSIS . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-JAN-2019: PLAINTIFF FACT SHEET RECEIVED. REPORTER INFORMATION UPDATED. REPORTER INFORMATION UPDATED. PRODUCT INDICATION FEMALE STERILIZATION UPDATED. PRODUCT INFORMATION DETAILS UPDATED. LAB DATA UPDATED. LOT NUMBER NEWLY ADDED. EVENTS: ABNORMAL BLEEDING VAGINAL, MENORRHAGIA, ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: HYPERSENSITIVITY, BLADDER DISORDER, URINARY TRACT DISORDER, BLOOD OR HEART DISORDER/CONDITION TYPE: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME, HORMONAL CHANGES DESCRIBE: MOOD SWINGS, MIGRAINES, HEADACHES, NAUSEA, NICKEL ALLERGY, DYSMENORRHEA (CRAMPING), FATIGUE, GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: IBS, EXCISION WITH ENDOMETRIOSIS, UEROSACRAL LIGAMENT SUSPENSION, CYSTOSCOPY/HYDRO DISTENSION, BLURRY VISION, WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN., HEAD NECK PAIN, LOW BACK PAIN, JOINT PAIN, ABDOMINAL PAIN WERE NEWLY ADDED. OUTCOME OF EVENT HAIR LOSS WAS CHANGED FROM "UNKNOWN" TO "RECOVERED/RESOLVED" AND EVENTS JOINT PAIN, PELVIC PAIN, PAIN WITH INTERCOURSE WERE CHANGED FROM "UNKNOWN" TO "RECOVERING/RESOLVING". INCIDENT: WE RECEIVED A LOT NUMBER/RETURNED SAMPLE IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), MAST CELL ACTIVATION SYNDROME ("MAST CELL ACTIVATION DISORDER") AND ENDOMETRIOSIS ABLATION ("EXCISION") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B21581) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OVERWEIGHT, HYPERTENSION, BACTERIAL VAGINOSIS, ADHD, FIBROMYALGIA, ASTHMA CHRONIC, VOCAL CORD DYSFUNCTION, EHLERS-DANLOS SYNDROME, LEFT LOWER QUADRANT PAIN, MENSTRUAL DISORDER, CYSTITIS INTERSTITIAL, MOOD ALTERED, HYPERTENSION, URINARY FREQUENCY, LEIOMYOMA NOS AND PAIN IN HIP. GROSS DESCRIPTION: RESULT. A. THE SPECIMEN IS RECEIVED FIXED IN FORMALIN IN ONE CONTAINER, LABELED WIT THE PATIENT'S WITH CERVIX AND BILATERAL FALLOPIAN TUBE" AND CONSISTS OF AN ALREADY BIVALVE:1 UTERUS MEASURING 8.2 CM X 7.4 CM X 6 2 CM PINK-TAN UTERUS. THE SEROSAL SURFACE IS SMOOTH AND GLISTENING AND PIRK-TAN. THE BIVALVE UTERUS SHOWS MULTIPLE YELLOW-TAN CIRCUMSCRIBED NODULES RANGING FROM 1.4 TOIL 3 CM IN GREATEST DIMENSION. THE ENTIRE SPECIMEN WEIGHS 69.9 GRAMS. THERE ARE HIE FALLOPIAN TUBES ATTACHED TO THE SPECIMEN. THE RIGHT 'RATIO-PLAN TUBE MEASURES 10.2 IX 0.5 URN AND THE LEFT FALLOPIAN TUBE MEASURES. 8.6 X 0 5 CM. THE ARE METAL STRINGS IN BOTH FALLOPIAN TUBES. REPRESENTATIVE SECTIONS ARE SUBMITTED AS FOLLOWS:. AL - ANTERIOR CERVIX. A2 - POSTERIOR CERVIX. A3 - ANTERIOR UTERUS WITH NODULE. A3 - ANTERIOR UTERUS WITH NODULE. A4- POSTERIOR UTERUS WITH NODULE. A5- NIGHT FALLOPIAN TUBE. A6 - LEFT FALLOPIAN TUBE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: CAMILA AND NUVARING. CONCOMITANT PRODUCTS INCLUDED (), AMFETAMINE ASPARTATE;AMFETAMINE SULFATE;DEXAMFETAMINE SACCHARATE;DEXAMFETAMINE SULFATE (ADDERALL), AZELASTINE HYDROCHLORIDE, BORIC ACID PRODUCTS, BOTULINUM TOXIN TYPE A (BOTOX), CETIRIZINE HYDROCHLORIDE, CLOBETASOL, ESTRADIOL (ESTROGEN), ESTROGENS CONJUGATED (PREMARIN), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), GLUCOSAMINE SULFATE (FLEXTRIL), INDOMETACIN, LISINOPRIL, LISINOPRIL (ZESTRIL), METOPROLOL, MOMETASONE FUROATE (ASMANEX), MONTELUKAST, ONDANSETRON HYDROCHLORIDE, PHENAZOPYRIDINE HYDROCHLORIDE (PYRIDIUM), PROPRANOLOL, RANITIDINE, SALBUTAMOL SULFATE (ALBUTEROL SULFATE), SUMATRIPTAN, TOPIRAMATE, TOPIRAMATE AND TRAZODONE. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALOPECIA ("HAIR LOSS"), MIGRAINE ("MIGRAINES"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL"), MENORRHAGIA ("MENORRHAGIA"), HYPERSENSITIVITY ("HYPERSENSITIVITY"), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME ("POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME"), MOOD SWINGS ("MOOD SWINGS"), HEADACHE ("HEADACHES / HEAD PAIN"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE") AND VISION BLURRED ("BLURRY VISION"). IN (B)(6) 2015, THE PATIENT EXPERIENCED DIARRHOEA ("DIARRHEA") AND CONSTIPATION ("CONSTIPATION"). IN 2015, THE PATIENT EXPERIENCED IRRITABLE BOWEL SYNDROME ("IBS"). IN (B)(6) 2015, THE PATIENT EXPERIENCED PHOTOPHOBIA ("LIGHT SENSITIVITY"). IN (B)(6) 2016, THE PATIENT EXPERIENCED CYSTITIS INTERSTITIAL ("BLADDER OR URINARY PROBLEMS OR CHANGES : CYSTITIS INTERSTITIAL"). IN 2017, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN."). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MAST CELL ACTIVATION SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), NECK PAIN ("HEAD NECK PAIN"), BACK PAIN ("LOW BACK PAIN"), ARTHRALGIA ("JOINT PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN") AND UNDERWENT ENDOMETRIOSIS ABLATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND BLADDER HYDRODISTENSION ("CYSTOSCOPY/HYDRO DISTENSION"). THE PATIENT WAS TREATED WITH SURGERY (EXCISION AND HYSTERECTOMY/SALPINGECTOMY (BILATERAL) AND UTEROSACRAL LIGAMENT SUSPENSION). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSPAREUNIA AND ARTHRALGIA WAS RESOLVING, THE MAST CELL ACTIVATION SYNDROME, ENDOMETRIOSIS ABLATION, MIGRAINE, VAGINAL HAEMORRHAGE, MENORRHAGIA, HYPERSENSITIVITY, CYSTITIS INTERSTITIAL, POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME, MOOD SWINGS, HEADACHE, NAUSEA, ALLERGY TO METALS, DYSMENORRHOEA, FATIGUE, IRRITABLE BOWEL SYNDROME, BLADDER HYDRODISTENSION, VISION BLURRED, WEIGHT INCREASED, NECK PAIN, BACK PAIN, ABDOMINAL PAIN, PHOTOPHOBIA, DIARRHOEA AND CONSTIPATION OUTCOME WAS UNKNOWN AND THE ALOPECIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, ARTHRALGIA, BACK PAIN, BLADDER HYDRODISTENSION, CONSTIPATION, CYSTITIS INTERSTITIAL, DIARRHOEA, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS ABLATION, FATIGUE, HEADACHE, HYPERSENSITIVITY, IRRITABLE BOWEL SYNDROME, MAST CELL ACTIVATION SYNDROME, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, NECK PAIN, PELVIC PAIN, PHOTOPHOBIA, POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME, VAGINAL HAEMORRHAGE, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: COILS SHOWING RIGHT SIDE 1, LEFT SIDE 1. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULT: THE LEFT TUBE CLOSED, NOT THE RIGHT; ON (B)(6) 2014: TOTAL BILATERAL OCCLUSION. CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS: DYSPAREUNIA, LOWER BACK PAIN, PELVIC PAIN, MENORRHAGIA, HEADACHE, MIGRAINES, ABDOMINAL PAIN, JOINT PAIN, DYSMENORRHEA, ENDOMETRIOSIS, UTEROSACRAL LIGAMENT SUSPENSION AND BACTERIAL VAGINOSIS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-APR-2019: PREVIOUSLY REPORTED EVENT "BLADDER OR URINARY PROBLEMS OR CHANGES" UPDATED TO "CYSTITIS INTERSTITIAL", EVENTS- "LIGHT SENSITIVITY, DIARRHEA, CONSTIPATION" ADDED FROM PFS. INCIDENT- WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN'), MAST CELL ACTIVATION SYNDROME ('MAST CELL ACTIVATION DISORDER') AND ENDOMETRIOSIS ABLATION ('EXCISION') IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B21581) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OVERWEIGHT, HYPERTENSION, BACTERIAL VAGINOSIS, ADHD, FIBROMYALGIA, ASTHMA CHRONIC, VOCAL CORD DYSFUNCTION, EHLERS-DANLOS SYNDROME, LEFT LOWER QUADRANT PAIN, MENSTRUAL DISORDER, CYSTITIS INTERSTITIAL, MOOD ALTERED, HYPERTENSION, URINARY FREQUENCY, LEIOMYOMA NOS AND PAIN IN HIP. GROSS DESCRIPTION: RESULT. A. THE SPECIMEN IS RECEIVED FIXED IN FORMALIN IN ONE CONTAINER, LABELED WIT THE PATIENT'S WITH CERVIX AND BILATERAL FALLOPIAN TUBE" AND CONSISTS OF AN ALREADY BIVALVE:1 UTERUS MEASURING 8.2 CM X 7.4 CM X 6 2 CM PINK-TAN UTERUS. THE SEROSAL SURFACE IS SMOOTH AND GLISTENING AND PIRK-TAN. THE BIVALVE UTERUS SHOWS MULTIPLE YELLOW-TAN CIRCUMSCRIBED NODULES RANGING FROM 1.4 TOIL 3 CM IN GREATEST DIMENSION. THE ENTIRE SPECIMEN WEIGHS 69.9 GRAMS. THERE ARE HIE FALLOPIAN TUBES ATTACHED TO THE SPECIMEN. THE RIGHT 'RATIO-PLAN TUBE MEASURES 10.2 IX 0.5 URN AND THE LEFT FALLOPIAN TUBE MEASURES. 8.6 X 0 5 CM. THE ARE METAL STRINGS IN BOTH FALLOPIAN TUBES. REPRESENTATIVE SECTIONS ARE SUBMITTED AS FOLLOWS:. AL - ANTERIOR CERVIX. A2 - POSTERIOR CERVIX. A3 - ANTERIOR UTERUS WITH NODULE. A3 - ANTERIOR UTERUS WITH NODULE. A4- POSTERIOR UTERUS WITH NODULE. A5- NIGHT FALLOPIAN TUBE. A6 - LEFT FALLOPIAN TUBE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: CAMILA AND NUVARING. CONCOMITANT PRODUCTS INCLUDED AMFETAMINE ASPARTATE;AMFETAMINE SULFATE;DEXAMFETAMINE SACCHARATE; DEXAMFETAMINE SULFATE (ADDERALL), AZELASTINE HYDROCHLORIDE, BORIC ACID PRODUCTS, BOTULINUM TOXIN TYPE A (BOTOX), CETIRIZINE HYDROCHLORIDE, CLOBETASOL, ESTRADIOL (ESTROGEN), ESTROGENS CONJUGATED (PREMARIN), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), GLUCOSAMINE SULFATE (FLEXTRIL), INDOMETACIN, LISINOPRIL, LISINOPRIL (ZESTRIL), METOPROLOL, MOMETASONE FUROATE (ASMANEX), MONTELUKAST, ONDANSETRON HYDROCHLORIDE, PHENAZOPYRIDINE HYDROCHLORIDE (PYRIDIUM), PROPRANOLOL, RANITIDINE, SALBUTAMOL SULFATE (ALBUTEROL SULFATE), SUMATRIPTAN, TOPIRAMATE, TOPIRAMATE AND TRAZODONE. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALOPECIA ("HAIR LOSS"), MIGRAINE ("MIGRAINES"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL/CLOT"), MENORRHAGIA ("MENORRHAGIA / CLOTS"), HYPERSENSITIVITY ("HYPERSENSITIVITY"), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME ("POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME / POTS"), MOOD SWINGS ("MOOD SWINGS"), HEADACHE ("HEADACHES / HEAD PAIN"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE") AND VISION BLURRED ("BLURRY VISION"). IN (B)(6) 2015, THE PATIENT EXPERIENCED DIARRHOEA ("DIARRHEA") AND CONSTIPATION ("CONSTIPATION"). IN 2015, THE PATIENT EXPERIENCED IRRITABLE BOWEL SYNDROME ("IBS"). IN NOVEMBER 2015, THE PATIENT EXPERIENCED PHOTOPHOBIA ("LIGHT SENSITIVITY"). IN (B)(6) 2016, THE PATIENT EXPERIENCED CYSTITIS INTERSTITIAL ("BLADDER OR URINARY PROBLEMS OR CHANGES : CYSTITIS INTERSTITIAL"). IN 2017, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN."). ON AN UNKNOWN DATE, THE PATIENT UNDERWENT ENDOMETRIOSIS ABLATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 4 YEARS 5 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MAST CELL ACTIVATION SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), NECK PAIN ("HEAD NECK PAIN"), BACK PAIN ("LOW BACK PAIN"), ARTHRALGIA ("JOINT PAIN/HIP PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND APHASIA ("APHASIA") AND UNDERWENT BLADDER HYDRODISTENSION ("CYSTOSCOPY/HYDRO DISTENSION"). THE PATIENT WAS TREATED WITH SURGERY (EXCISION AND HYSTERECTOMY/SALPINGECTOMY (BILATERAL) AND UTEROSACRAL LIGAMENT SUSPENSION). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSPAREUNIA AND ARTHRALGIA WAS RESOLVING, THE MAST CELL ACTIVATION SYNDROME, ENDOMETRIOSIS ABLATION, MIGRAINE, VAGINAL HAEMORRHAGE, MENORRHAGIA, HYPERSENSITIVITY, CYSTITIS INTERSTITIAL, POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME, MOOD SWINGS, HEADACHE, NAUSEA, ALLERGY TO METALS, DYSMENORRHOEA, FATIGUE, IRRITABLE BOWEL SYNDROME, BLADDER HYDRODISTENSION, VISION BLURRED, WEIGHT INCREASED, NECK PAIN, BACK PAIN, ABDOMINAL PAIN, PHOTOPHOBIA, DIARRHOEA, CONSTIPATION AND APHASIA OUTCOME WAS UNKNOWN AND THE ALOPECIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, APHASIA, ARTHRALGIA, BACK PAIN, BLADDER HYDRODISTENSION, CONSTIPATION, CYSTITIS INTERSTITIAL, DIARRHOEA, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS ABLATION, FATIGUE, HEADACHE, HYPERSENSITIVITY, IRRITABLE BOWEL SYNDROME, MAST CELL ACTIVATION SYNDROME, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, NECK PAIN, PELVIC PAIN, PHOTOPHOBIA, POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME, VAGINAL HAEMORRHAGE, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: COILS SHOWING RIGHT SIDE 1, LEFT SIDE 1. LEGACY DEVICE REPORT NUM 2951250-2020-06031 MEDWATCH 3500A MFR NUMBER. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULT: THE LEFT TUBE CLOSED, NOT THE RIGHT; ON (B)(6) 2014: TOTAL BILATERAL OCCLUSION. CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS: DYSPAREUNIA, LOWER BACK PAIN, PELVIC PAIN, MENORRHAGIA, HEADACHE, MIGRAINES, ABDOMINAL PAIN, JOINT PAIN, DYSMENORRHEA, ENDOMETRIOSIS, UTEROSACRAL LIGAMENT SUSPENSION AND BACTERIAL VAGINOSIS CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONES WERE DESCRIBED VIA SOCIAL MEDIA: CLOTS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: THIS RECORD WAS DETECTED TO BE A DUPLICATE TO RECORD (B)(4) WHICH WILL BE DELETED FROM BAYER SAFETY DATABASE AFTER ALL INFORMATION WAS TRANSFERRED TO THIS RECORD (B)(4) WHICH WILL BE RETAINED. FROM DELETION CASE (B)(4) REPORTER INFORMATION WERE ADDED. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN ") AND MAST CELL ACTIVATION SYNDROME ("MAST CELL ACTIVATION DISORDER") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MAST CELL ACTIVATION SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ALOPECIA ("HAIR LOSS"), MIGRAINE ("MIGRAINES") AND DYSPAREUNIA ("PAINFUL INTERCOURSE"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE IMPLANT REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MAST CELL ACTIVATION SYNDROME, ALOPECIA, MIGRAINE AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, DYSPAREUNIA, MAST CELL ACTIVATION SYNDROME, MIGRAINE AND PELVIC PAIN TO BE RELATED TO ESSURE. INCIDENT. NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 331295 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | B21581 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other| R | ADDERALL| ADDERALL| ADDERALL| ADDERALL| ADDERALL| ADDERALL| AIMOVIG| AIMOVIG| ALBUTEROL SULFATE| ALBUTEROL SULFATE| ALBUTEROL SULFATE| ALBUTEROL SULFATE| ALBUTEROL SULFATE| ALBUTEROL SULFATE| ALLEGRA| ALLEGRA| ALLEGRA| ALLEGRA| ALLEGRA| ALLEGRA| ASMANEX| ASMANEX| ASMANEX| ASMANEX| ASMANEX| ASMANEX| AZELASTINE HYDROCHLORIDE| AZELASTINE HYDROCHLORIDE| AZELASTINE HYDROCHLORIDE| AZELASTINE HYDROCHLORIDE| AZELASTINE HYDROCHLORIDE| AZELASTINE HYDROCHLORIDE| BORIC ACID PRODUCTS| BORIC ACID PRODUCTS| BORIC ACID PRODUCTS| BORIC ACID PRODUCTS| BORIC ACID PRODUCTS| BORIC ACID PRODUCTS| BOTOX| BOTOX| BOTOX| BOTOX| BOTOX| BOTOX| CETIRIZINE HYDROCHLORIDE| CETIRIZINE HYDROCHLORIDE| CETIRIZINE HYDROCHLORIDE| CETIRIZINE HYDROCHLORIDE| CETIRIZINE HYDROCHLORIDE| CETIRIZINE HYDROCHLORIDE| CLOBETASOL| CLOBETASOL| CLOBETASOL| CLOBETASOL| CLOBETASOL| CLOBETASOL| ESTROGEN| ESTROGEN| ESTROGEN| ESTROGEN| ESTROGEN| ESTROGEN| FLEXTRIL| FLEXTRIL| FLEXTRIL| FLEXTRIL| FLEXTRIL| FLEXTRIL| INDOMETACIN| INDOMETACIN| INDOMETACIN| INDOMETACIN| INDOMETACIN| INDOMETACIN| LISINOPRIL| LISINOPRIL| LISINOPRIL| LISINOPRIL| LISINOPRIL| LISINOPRIL| METOPROLOL| METOPROLOL| METOPROLOL| METOPROLOL| METOPROLOL| METOPROLOL| MONTELUKAST| MONTELUKAST| MONTELUKAST| MONTELUKAST| MONTELUKAST| MONTELUKAST| ONDANSETRON HYDROCHLORIDE| ONDANSETRON HYDROCHLORIDE| ONDANSETRON HYDROCHLORIDE| ONDANSETRON HYDROCHLORIDE| ONDANSETRON HYDROCHLORIDE| ONDANSETRON HYDROCHLORIDE| PREMARIN| PREMARIN| PREMARIN| PREMARIN| PREMARIN| PREMARIN| PROPRANOLOL| PROPRANOLOL| PROPRANOLOL| PROPRANOLOL| PROPRANOLOL| PROPRANOLOL| PYRIDIUM| PYRIDIUM| PYRIDIUM| PYRIDIUM| PYRIDIUM| PYRIDIUM| RANITIDINE| RANITIDINE| RANITIDINE| RANITIDINE| RANITIDINE| RANITIDINE| SUMATRIPTAN| SUMATRIPTAN| SUMATRIPTAN| SUMATRIPTAN| SUMATRIPTAN| SUMATRIPTAN| TOPIRAMATE| TOPIRAMATE| TOPIRAMATE| TOPIRAMATE| TOPIRAMATE| TOPIRAMATE| TOPIRAMATE| TOPIRAMATE| TOPIRAMATE| TOPIRAMATE| TOPIRAMATE| TOPIRAMATE| TRAZODONE| TRAZODONE| TRAZODONE| TRAZODONE| TRAZODONE| TRAZODONE| ZESTRIL| ZESTRIL| ZESTRIL| ZESTRIL| ZESTRIL| ZESTRIL |