| Model Number ESS305 |
| Device Problems
Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
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| Patient Problems
Abdominal Pain (1685); Diarrhea (1811); Emotional Changes (1831); Fatigue (1849); Flatus (1865); Headache (1880); Hemorrhage/Bleeding (1888); Nausea (1970); Neurological Deficit/Dysfunction (1982); Pain (1994); Rash (2033); Uterine Perforation (2121); Abnormal Vaginal Discharge (2123); Depression (2361); Abdominal Cramps (2543); Abdominal Distention (2601); Heavier Menses (2666); Foreign Body In Patient (2687); Cancer (3262)
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Event Type
Injury
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Event Description
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This case was initially received via regulatory authority ((b)(4), reference number: mw5059512) on (b)(6) 2016.The most recent information was received on 28-feb-2018.This spontaneous case was reported by a lawyer and describes the occurrence of uterine polyp ("uterina polyps"), neoplasm malignant ("tumor / teratoma / cancer (event splitted for coding)") and pelvic pain ("pain") in a (b)(6) -year-old female patient who had essure (batch no.A64629) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included asthma, bacterial vaginosis, cervical dysplasia, irritable bowel syndrome, vaginal candidiasis, endometrial polyp since (b)(6) 2014 and pregnancy induced hypertension since 2012.Concomitant products included breo ellipta, cetirizine hydrochloride (zyrtec), fluticasone propionate (flovent), ibuprofen, lorazepam, medroxyprogesterone (depo provera), misoprostol, oxycocet (acetaminophen w/oxycodone), phentermine, salbutamol sulfate (proair hfa) and seretide (advair).On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced uterine polyp (seriousness criterion hospitalization) with menorrhagia, dyspareunia ("painful sex /dyspareunia (painful sexual intercourse)"), depression ("depression"), abdominal pain ("constant abdominal pain"), hormone level abnormal ("hormonal changes"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia) (event splitted for coding)"), mental disorder ("psychological or psychiatric problems"), rash ("rashes or skin conditions"), migraine ("migraines / headaches (event splitted for coding)"), headache ("migraines / headaches (event splitted for coding)"), uterine perforation ("migration of essure device location of device: uterus"), nausea ("nausea"), nervous system disorder ("neurological conditions or problems"), dysmenorrhoea ("dysmenorrhea (cramping)"), neoplasm ("tumor / teratoma / cancer (event splitted for coding)"), teratoma ("tumor / teratoma / cancer (event splitted for coding)"), neoplasm malignant (seriousness criterion medically significant), pelvic pain (seriousness criteria medically significant and intervention required), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), abdominal distension ("bloating"), diarrhoea ("loose stools") and back pain ("back pain").The patient was treated with surgery and surgery ((b)(6) 2015, total hysterectomy (uterus and cervix removed)).Essure was removed on (b)(6) 2015.In (b)(6) 2015, the uterine polyp, dyspareunia, depression and abdominal pain had resolved.At the time of the report, the hormone level abnormal, vaginal haemorrhage, mental disorder, rash, migraine, headache, uterine perforation, nausea, nervous system disorder, dysmenorrhoea, neoplasm, teratoma, neoplasm malignant, pelvic pain, vaginal discharge, fatigue, abdominal distension, diarrhoea and back pain had resolved.The reporter considered abdominal distension, abdominal pain, back pain, depression, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, headache, hormone level abnormal, mental disorder, migraine, nausea, neoplasm, neoplasm malignant, nervous system disorder, pelvic pain, rash, teratoma, uterine perforation, uterine polyp, vaginal discharge and vaginal haemorrhage to be related to essure.The reporter commented: previously reported date of essure insertion was (b)(6) 2013, and stop date was (b)(6) 2015.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: total bilateral occlusion; on (b)(6) 2014: total bilateral occlusion most recent follow-up information incorporated above includes: on (b)(6) 2018: pfs received.Patient details, concomitant disease, concomitant drugs and lab data were added.Hormonal changes, abnormal bleeding (vaginal, menorrhagia), psychological or psychiatric problems, rashes or skin conditions, migraines / headaches, migration of essure device location of device: uterus, nausea, neurological conditions or problems, dysmenorrhea (cramping), tumor / teratoma / cancer, pain, vaginal discharge, fatigue, bloating, loose stools and back pain were added as events.Essure lot number was added.Essure legal manufacture has changed from bayer healthcare, (b)(4) to bayer (b)(4), and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only.At the time of reporting, 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.
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Manufacturer Narrative
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This case was initially received via regulatory authority (food and drug administration, reference number: mw5059512) on 29-mar-2016.The most recent information was received on 23-apr-2018.This spontaneous case was reported by a lawyer and describes the occurrence of uterine polyp ("uterian polyps"), neoplasm malignant ("tumor / teratoma / cancer ") and pelvic pain ("pain") in a 32-year-old female patient who had essure (batch no.A64629) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included asthma, bacterial vaginosis, cervical dysplasia, irritable bowel syndrome, vaginal candidiasis, endometrial polyp since (b)(6) 2014 and pregnancy induced hypertension since 2012.Concomitant products included breo ellipta, cetirizine hydrochloride (zyrtec), fluticasone propionate (flovent), ibuprofen, lorazepam, medroxyprogesterone (depo provera), misoprostol, oxycocet (acetaminophen w/oxycodone), phentermine, salbutamol sulfate (proair hfa) and seretide (advair).On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced uterine polyp (seriousness criterion hospitalization) with menorrhagia, dyspareunia ("painful sex /dyspareunia (painful sexual intercourse)"), depression ("depression"), abdominal pain ("constant abdominal pain"), hormone level abnormal ("hormonal changes"), vaginal haemorrhage ("abnormal bleeding(vaginal, menorrhagia) (event splitted for coding)"), mental disorder ("psychological or psychiatric problems"), rash ("rashes or skin conditions"), migraine ("migraines / headaches (event splitted for coding)"), headache ("migraines / headaches (event splitted for coding)"), device expulsion ("migration of essure device location of device: uterus"), nausea ("nausea"), nervous system disorder ("neurological conditions or problems"), dysmenorrhoea ("dysmenorrhea (cramping)"), neoplasm ("tumor / teratoma / cancer"), teratoma ("tumor / teratoma / cancer "), neoplasm malignant (seriousness criterion medically significant), pelvic pain (seriousness criteria medically significant and intervention required), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), abdominal distension ("bloating"), diarrhoea ("loose stools") and back pain ("back pain").The patient was treated with surgery and surgery ((b)(6) 2015, total hysterectomy (uterus and cervix removed)).Essure was removed on (b)(6) 2015.In (b)(6) 2015, the uterine polyp, dyspareunia, depression and abdominal pain had resolved.At the time of the report, the hormone level abnormal, vaginal haemorrhage, mental disorder, rash, migraine, headache, device expulsion, nausea, nervous system disorder, dysmenorrhoea, neoplasm, teratoma, neoplasm malignant, pelvic pain, vaginal discharge, fatigue, abdominal distension, diarrhoea and back pain had resolved.The reporter considered abdominal distension, abdominal pain, back pain, depression, device expulsion, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, headache, hormone level abnormal, mental disorder, migraine, nausea, neoplasm, neoplasm malignant, nervous system disorder, pelvic pain, rash, teratoma, uterine polyp, vaginal discharge and vaginal haemorrhage to be related to essure.The reporter commented: previously reported date of essure insertion was (b)(6) 2013, and stop date was (b)(6) 2015.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: total bilateral occlusion; on (b)(6) 2014: total bilateral occlusion most recent follow-up information incorporated above includes: on 23-apr-2018: following company internal coding review, the reported event "migration of essure device location of device: uterus" was recoded to the meddra llt: partial expulsion of device and the reported event "tumor / teratoma / cancer (event splitted for coding)" was recoded to the meddra llt: neoplasm nos.Narrative amended.Incident at the time of reporting, 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.
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Manufacturer Narrative
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E was initially received via regulatory authority (food and drug administration, reference number: mw5059512) on 29-mar-2016.The most recent information was received on 07-aug-2018.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain"), device expulsion ("migration of essure device location of device: uterus"), uterine polyp ("uterine polyps/endometrial polyp") and neoplasm malignant ("tumor / teratoma / cancer") in a 32-year-old female patient who had essure (batch no.A64629) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included asthma, bacterial vaginosis, cervical dysplasia, irritable bowel syndrome, vaginal candidiasis, endometrial polyp since (b)(6) 2014, pregnancy induced hypertension since 2012, mass and irregular menstruation.Concomitant products included breo ellipta, cetirizine hydrochloride (zyrtec), fluticasone propionate (flovent), ibuprofen, lorazepam, medroxyprogesterone (depo provera), misoprostol, oxycocet (acetaminophen w/oxycodone), phentermine, salbutamol sulfate (proair hfa) and seretide (advair).In (b)(6) 2013, the patient experienced dyspareunia ("painful sex /dyspareunia (painful sexual intercourse)"), vaginal haemorrhage ("abnormal bleeding(vaginal, menorrhagia)"), dysmenorrhoea ("dysmenorrhea (cramping)"), vaginal discharge ("vaginal discharge") and fatigue ("fatigue").On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced migraine ("migraines / headaches "), headache ("migraines / headaches") and nausea ("nausea").On (b)(6) 2013, 2 months 25 days after insertion of essure, the patient experienced uterine polyp (seriousness criterion hospitalization) with menorrhagia.In (b)(6) 2013, the patient experienced abdominal distension ("bloating").In (b)(6) 2014, the patient experienced irritability ("irritability/almost right away i left irritable").In (b)(6) 2014, the patient experienced depression ("depression").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), abdominal pain ("constant abdominal pain"), hormone level abnormal ("hormonal changes"), mental disorder ("psychological or psychiatric problems"), rash ("rashes or skin conditions"), nervous system disorder ("neurological conditions or problems"), neoplasm ("tumor / teratoma / cancer"), teratoma ("tumor / teratoma / cancer "), neoplasm malignant (seriousness criterion medically significant), diarrhoea ("loose stools") and back pain ("back pain").The patient was treated with surgery ((b)(6) 2015, total hysterectomy (uterus and cervix removed)), surgery ((b)(6) 2015, total hysterectomy (uterus and cervix removed)) and surgery.Essure was removed on (b)(6) 2015.In (b)(6) 2015, the uterine polyp, dyspareunia, depression and abdominal pain had resolved.At the time of the report, the pelvic pain, device expulsion, hormone level abnormal, vaginal haemorrhage, mental disorder, rash, migraine, headache, nausea, nervous system disorder, dysmenorrhoea, neoplasm, teratoma, neoplasm malignant, vaginal discharge, fatigue, abdominal distension, diarrhoea and back pain had resolved and the irritability outcome was unknown.The reporter considered abdominal distension, abdominal pain, back pain, depression, device expulsion, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, headache, hormone level abnormal, irritability, mental disorder, migraine, nausea, neoplasm, neoplasm malignant, nervous system disorder, pelvic pain, rash, teratoma, uterine polyp, vaginal discharge and vaginal haemorrhage to be related to essure.The reporter commented: previously reported date of essure insertion was (b)(6) 2013, and stop date was (b)(6) 2015.Insertion detail: procedure: 7 coils were trailing from the right fallopian tube.4 coils were trailing from the left fallopian tube.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: total bilateral occlusion; on (b)(6) 2014: total bilateral occlusion.Pregnancy test - on (b)(6) 2013: negative.Intensity of pain: 4/10.¿concerning the injuries reported in this case, the following ones were described in patients medical record: dyspareunia, endometrial polyp, menorrhagia, nausea, vaginal discharge." quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 7-aug-2018: quality safety evaluation of ptc(product technical complaint).Incident at the time of reporting, 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.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain"), device expulsion ("migration of essure device location of device: uterus"), uterine polyp ("uterine polyps/endometrial polyp") and neoplasm malignant ("tumor / teratoma / cancer") in a 32-year-old female patient who had essure (batch no.A64629) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included asthma, bacterial vaginosis, cervical dysplasia, irritable bowel syndrome, vaginal candidiasis, endometrial polyp since (b)(6)2014, pregnancy induced hypertension since 2012, mass nos and irregular menstruation.Concomitant products included breo ellipta, cetirizine hydrochloride (zyrtec), fluticasone propionate (flovent), ibuprofen, lorazepam, medroxyprogesterone (depo provera), misoprostol, oxycocet (acetaminophen w/oxycodone), phentermine, salbutamol sulfate (proair hfa) and seretide (advair).On (b)(6) 2013, the patient had essure inserted.In august 2013, the patient experienced dyspareunia ("painful sex /dyspareunia (painful sexual intercourse)"), vaginal haemorrhage ("abnormal bleeding(vaginal, menorrhagia)"), dysmenorrhoea ("dysmenorrhea (cramping)"), vaginal discharge ("vaginal discharge") and fatigue ("fatigue").In september 2013, the patient experienced migraine ("migraines / headaches "), headache ("migraines / headaches") and nausea ("nausea").On (b)(6) 2013, 2 months 25 days after insertion of essure, the patient experienced uterine polyp (seriousness criterion hospitalization) with menorrhagia.In december 2013, the patient experienced abdominal distension ("bloating").In september 2014, the patient experienced irritability ("irritability/almost right away i left irritable").In october 2014, the patient experienced depression ("depression").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), abdominal pain ("constant abdominal pain"), hormone level abnormal ("hormonal changes"), mental disorder ("psychological or psychiatric problems"), rash ("rashes or skin conditions"), nervous system disorder ("neurological conditions or problems"), neoplasm ("tumor / teratoma / cancer"), teratoma ("tumor / teratoma / cancer "), neoplasm malignant (seriousness criterion medically significant), diarrhoea ("loose stools") and back pain ("back pain").The patient was treated with surgery (b)(6) 2015, total hysterectomy (uterus and cervix removed)), surgery (b)(6) 2015, total hysterectomy (uterus and cervix removed)) and surgery.Essure was removed on (b)(6) 2015.In february 2015, the uterine polyp, dyspareunia, depression and abdominal pain had resolved.At the time of the report, the pelvic pain, device expulsion, hormone level abnormal, vaginal haemorrhage, mental disorder, rash, migraine, headache, nausea, nervous system disorder, dysmenorrhoea, neoplasm, teratoma, neoplasm malignant, vaginal discharge, fatigue, abdominal distension, diarrhoea and back pain had resolved and the irritability outcome was unknown.The reporter considered abdominal distension, abdominal pain, back pain, depression, device expulsion, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, headache, hormone level abnormal, irritability, mental disorder, migraine, nausea, neoplasm, neoplasm malignant, nervous system disorder, pelvic pain, rash, teratoma, uterine polyp, vaginal discharge and vaginal haemorrhage to be related to essure.The reporter commented: previously reported date of essure insertion was (b)(6) 2013, and stop date was (b)(6) 2015.Insertion detail: procedure: 7 coils were trailing from the right fallopian tube.4 coils were trailing from the left fallopian tube.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: total bilateral occlusion; on (b)(6) 2014: total bilateral occlusion pregnancy test - on (b)(6) 2013: negative intensity of pain: 4/10.¿concerning the injuries reported in this case, the following ones were described in patients medical record: dyspareunia, endometrial polyp, menorrhagia, nausea, vaginal discharge." most recent follow-up information incorporated above includes: on (b)(6) 2018: reporter information was added.Her concurrent conditions were added.Lab data was added.Event: irritability/almost right away i left irritable was added.She had recovered from events: heavy bleeding and pelvic pain.Incident at the time of reporting, 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.
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Manufacturer Narrative
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E was initially received via regulatory authority (food and drug administration, reference number: (b)(4)) on (b)(6)2016.The most recent information was received on (b)(6) 2018.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain"), device expulsion ("migration of essure device location of device: uterus"), uterine polyp ("uterine polyps/endometrial polyp") and neoplasm malignant ("tumor / teratoma / cancer") in a 32-year-old female patient who had essure (batch no.A64629) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included asthma, bacterial vaginosis, cervical dysplasia, irritable bowel syndrome, vaginal candidiasis, endometrial polyp since (b)(6) 2014, pregnancy induced hypertension since 2012, mass and irregular menstruation.Concomitant products included breo ellipta, cetirizine hydrochloride (zyrtec), fluticasone propionate (flovent), ibuprofen, lorazepam, medroxyprogesterone (depo provera), misoprostol, oxycocet (acetaminophen w/oxycodone), phentermine, salbutamol sulfate (proair hfa) and seretide (advair).In (b)(6) 2013, the patient experienced dyspareunia ("painful sex /dyspareunia (painful sexual intercourse)"), vaginal haemorrhage ("abnormal bleeding(vaginal, menorrhagia)"), dysmenorrhoea ("dysmenorrhea (cramping)"), vaginal discharge ("vaginal discharge") and fatigue ("fatigue").On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced migraine ("migraines / headaches "), headache ("migraines / headaches") and nausea ("nausea").On (b)(6) 2013, 2 months 25 days after insertion of essure, the patient experienced uterine polyp (seriousness criterion hospitalization) with menorrhagia.In (b)(6) 2013, the patient experienced abdominal distension ("bloating").In (b)(6) 2014, the patient experienced irritability ("irritability/almost right away i left irritable").In (b)(6) 2014, the patient experienced depression ("depression").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), abdominal pain ("constant abdominal pain"), hormone level abnormal ("hormonal changes"), mental disorder ("psychological or psychiatric problems"), rash ("rashes or skin conditions"), nervous system disorder ("neurological conditions or problems"), neoplasm ("tumor / teratoma / cancer"), teratoma ("tumor / teratoma / cancer "), neoplasm malignant (seriousness criterion medically significant), diarrhoea ("loose stools") and back pain ("back pain").The patient was treated with surgery ((b)(6)2015, total hysterectomy (uterus and cervix removed)), surgery ((b)(6)2015, total hysterectomy (uterus and cervix removed)) and surgery.Essure was removed on (b)(6)2015.In (b)(6) 2015, the uterine polyp, dyspareunia, depression and abdominal pain had resolved.At the time of the report, the pelvic pain, device expulsion, hormone level abnormal, vaginal haemorrhage, mental disorder, rash, migraine, headache, nausea, nervous system disorder, dysmenorrhoea, neoplasm, teratoma, neoplasm malignant, vaginal discharge, fatigue, abdominal distension, diarrhoea and back pain had resolved and the irritability outcome was unknown.The reporter considered abdominal distension, abdominal pain, back pain, depression, device expulsion, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, headache, hormone level abnormal, irritability, mental disorder, migraine, nausea, neoplasm, neoplasm malignant, nervous system disorder, pelvic pain, rash, teratoma, uterine polyp, vaginal discharge and vaginal haemorrhage to be related to essure.The reporter commented: previously reported date of essure insertion was (b)(6)2013, and stop date was (b)(6)2015.Insertion detail: procedure: 7 coils were trailing from the right fallopian tube.4 coils were trailing from the left fallopian tube.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: total bilateral occlusion; on (b)(6) 2014: total bilateral occlusion pregnancy test - on (b)(6) 2013: negative intensity of pain: 4/10.¿concerning the injuries reported in this case, the following ones were described in patients medical record: dyspareunia, endometrial polyp, menorrhagia, nausea, vaginal discharge." quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2018: quality safety evaluation of product technical complaint.Incident at the time of reporting, 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.
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Search Alerts/Recalls
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