| Model Number ESS305 |
| Device Problems
Device Inoperable (1663); Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Abortion (1688); Dehydration (1807); Headache (1880); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Vomiting (2144); Abdominal Cramps (2543); Foreign Body In Patient (2687); Pregnancy (3193); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 05/04/2012 |
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Event Type
Injury
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Event Description
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This retrospective pregnancy case was reported by a lawyer and describes the occurrence of device dislocation ("device dislocation in lt tube"), pelvic pain ("pain constant mild pain in pelvis/infrequent severe pain in pelvis/ severe pelvic pain"), hyperemesis gravidarum ("termination of pregnancy due to severe nausea, vomiting/ hyperemesis gravidarium-severe") and pregnancy with contraceptive device ("an unwanted pregnancy/ pregnancy (with complications/pregnancy termination)") in a (b)(6) female patient who had essure (batch no.952110) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective" and device monitoring procedure not performed "she did not undergo essure confirmation test".The patient's past medical history included multigravida, live birth on (b)(6) 2010, live birth on (b)(6) 2012, gestational hypertension, vaginal haemorrhage, headache, elevated bp, loop electrosurgical excision procedure in 2006, cervical dysplasia, hemorrhoids, parity 2 ((b)(6) 2010 and (b)(6) 2012) and vaginal deliveries), pre-eclampsia and premature birth.Concurrent conditions included body mass index normal, numbness in hand, anxious mood (all pregnancies before have given her similar symptoms where she becomes very anxious and has uncontrollable nausea and vomiting noted.), chest tightness, chest pain, pelvic inflammatory disease, shortness of breath and procedural bleeding.Concomitant products included medroxyprogesterone acetate (depo-provera) from 2011 to 2013 for birth control as well as metoclopramide (reglan) since 2013, ondansetron (zofran) since 2013 and promethazine (phenergan) since 2013.On (b)(6) 2012, the patient had essure inserted.On the same day, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required) and complication of device insertion ("malposition of essure device (lt tube not occluded)/ dr was unable to insert the lt coil/ failure to occlude (close)").In (b)(6) 2012, the patient experienced migraine ("migraines/headaches").In (b)(6) 2012, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)/ cramping with periods / severe abnormal menstrual pain/").In 2013, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).In july 2013, the patient experienced hyperemesis gravidarum (seriousness criterion medically significant).On (b)(6) 2013, the patient experienced vomiting ("vomiting / became pregnant with excessive vomiting").On an unknown date, the patient experienced menorrhagia ("excessive and abnormal bleeding during menstruation/"), dehydration ("she was becoming dehydrated"), nausea ("severe nausea"), abdominal pain lower ("lower abdomen pain constant mild pain since essure, infrequently the pain would become severe in that area") and headache ("headaches").On an unknown date, the patient experienced abdominal pain ("constant cramping/ pain constant mild pain in abdomen/infrequent severe pain in abdomen/ abdominal pain").Last menstrual period and estimated date of delivery were not provided.The patient had essure during the first trimester of pregnancy.The patient was treated with surgery (salpingectomy (bilateral removal of fallopian tubes)), surgery (elective abortion, d&c) and surgery (bilateral salpingectomy).Essure was removed on (b)(6) 2013.At the time of the report, the device dislocation, pelvic pain, hyperemesis gravidarum, pregnancy with contraceptive device, complication of device insertion, menorrhagia, dehydration, nausea, vomiting, abdominal pain, abdominal pain lower and headache outcome was unknown and the migraine and dysmenorrhoea had resolved.The pregnancy outcome was reported as elective abortion.The reporter considered abdominal pain, abdominal pain lower, complication of device insertion, dehydration, device dislocation, dysmenorrhoea, headache, hyperemesis gravidarum, menorrhagia, migraine, nausea, pelvic pain, pregnancy with contraceptive device and vomiting to be related to essure.The reporter commented: discussed that essure did not work; pregnancy symptoms were the worst i ever experienced and were threatening the viability of the baby and i was becoming dehydrated & unable to do my normal activities, go to work; discussed removal and permanent tubal ligation.Multiple er visits, hospital visits requiring iv fluid replacements: multiple dr visits trying to get nausea, vomiting, headaches, abdominal pain & cramping under control.These symptoms were unrelieved by prescription medications.These symptoms were severe enough that it was interfering with my ability to work, take care of my other children and my own health.Drs recommended that i terminate the pregnancy and get essure removed.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.3 kg/sqm.Current weight was (b)(6).On (b)(6) 2013, she had on surgical pathology report of fallopian tubes left salpingectomy and right salpingectomy shows benign paratubal cysts.Concerning the injuries reported in this case, the following one was described in patient's medical records: complication of device insertion and pregnancy with contraceptive device.Most recent follow-up information incorporated above includes: on (b)(6) 2018: event device dislocation in lt tube," reporter added from pfs.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 prospective pregnancy case was reported by a lawyer and describes the occurrence of device dislocation ("device dislocation in lt tube"), pelvic pain ("pain constant mild pain in pelvis/infrequent severe pain in pelvis/ severe pelvic pain"), hyperemesis gravidarum ("termination of pregnancy due to severe nausea, vomiting/ hyperemesis gravidarium-severe") and pregnancy with contraceptive device ("an unwanted pregnancy/ pregnancy (with complications/pregnancy termination)") in a 25-year-old female patient who had essure (batch no.952110) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective" and device monitoring procedure not performed "she did not undergo essure confirmation test".The patient's past medical history included multigravida, live birth on (b)(6) 2010, live birth on (b)(6)2012, gestational hypertension, vaginal haemorrhage, headache, elevated bp, loop electrosurgical excision procedure in 2006, cervical dysplasia, hemorrhoids, parity 2 ((b)(6) 2010 and (b)(6) 2012) and vaginal deliveries), pre-eclampsia and premature birth.Concurrent conditions included body mass index normal, numbness in hand, anxious mood (all pregnancies before have given her similar symptoms where she becomes very anxious and has uncontrollable nausea and vomiting noted.), chest tightness, chest pain, pelvic inflammatory disease, shortness of breath and procedural bleeding.Concomitant products included medroxyprogesterone acetate (depo-provera) from 2011 to 2013 for birth control as well as metoclopramide (reglan) since 2013, ondansetron (zofran) since 2013 and promethazine (phenergan) since 2013.On(b)(6) 2012, the patient had essure inserted.On the same day, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required) and complication of device insertion ("malposition of essure device (lt tube not occluded)/ dr was unable to insert the lt coil/ failure to occlude (close)").In (b)(6) 2012, the patient experienced migraine ("migraines/headaches").In (b)(6) 2012, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)/ cramping with periods / severe abnormal menstrual pain/").In 2013, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).In (b)(6) 2013, the patient experienced hyperemesis gravidarum (seriousness criterion medically significant).On (b)(6) 2013, the patient experienced vomiting ("vomiting / became pregnant with excessive vomiting").On an unknown date, the patient experienced menorrhagia ("excessive and abnormal bleeding during menstruation/"), dehydration ("she was becoming dehydrated"), nausea ("severe nausea"), abdominal pain lower ("lower abdomen pain constant mild pain since essure, infrequently the pain would become severe in that area") and headache ("headaches").On an unknown date, the patient experienced abdominal pain ("constant cramping/ pain constant mild pain in abdomen/infrequent severe pain in abdomen/ abdominal pain").Last menstrual period and estimated date of delivery were not provided.The patient had essure during the first trimester of pregnancy.The patient was treated with surgery (salpingectomy (bilateral removal of fallopian tubes)), surgery (salpingectomy (bilateral removal of fallopian tubes)), surgery (elective abortion, d&c) and surgery (bilateral salpingectomy).Essure was removed on (b)(6) 2013.At the time of the report, the device dislocation, pelvic pain, hyperemesis gravidarum, pregnancy with contraceptive device, complication of device insertion, menorrhagia, dehydration, nausea, vomiting, abdominal pain, abdominal pain lower and headache outcome was unknown and the migraine and dysmenorrhoea had resolved.The pregnancy outcome was reported as elective abortion.The reporter considered abdominal pain, abdominal pain lower, complication of device insertion, dehydration, device dislocation, dysmenorrhoea, headache, hyperemesis gravidarum, menorrhagia, migraine, nausea, pelvic pain, pregnancy with contraceptive device and vomiting to be related to essure.The reporter commented: discussed that essure did not work; pregnancy symptoms were the worst i ever experienced and were threatening the viability of the baby and i was becoming dehydrated & unable to do my normal activities, go to work; discussed removal and permanent tubal ligation.Multiple er visits, hospital visits requiring iv fluid replacements: multiple dr visits trying to get nausea, vomiting, headaches, abdominal pain & cramping under control.These symptoms were unrelieved by prescription medications.These symptoms were severe enough that it was interfering with my ability to work, take care of my other children and my own health.Drs recommended that i terminate the pregnancy and get essure removed.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.3 kg/sqm.Current weight was 155 lbs.On (b)(6) 2013, she had on surgical pathology report of fallopian tubes left salpingectomy and right salpingectomy shows benign paratubal cysts.Concerning the injuries reported in this case, the following one was described in patient's medical records: complication of device insertion and pregnancy with contraceptive device.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 complaints.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 device dislocation ('device dislocation in lt tube'), pelvic pain ('pain constant mild pain in pelvis/infrequent severe pain in pelvis/ severe pelvic pain'), hyperemesis gravidarum ('termination of pregnancy due to severe nausea, vomiting/ hyperemesis gravidarium-severe') and pregnancy with contraceptive device ('an unwanted pregnancy/ pregnancy (with complications/pregnancy termination)') in a 25-year-old female patient who had essure (batch no.952110) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective" and device monitoring procedure not performed "she did not undergo essure confirmation test".The patient's medical history included live birth on (b)(6) 2012, live birth on (b)(6) 2010, loop electrosurgical excision procedure in 2006, multigravida, gestational hypertension, vaginal haemorrhage, headache, elevated bp, cervical dysplasia, hemorrhoids, parity 2 ((b)(6) 2010 and (b)(6) 2012) and vaginal deliveries), pre-eclampsia and premature birth.Concurrent conditions included body mass index normal, numbness in hand, anxious mood (all pregnancies before have given her similar symptoms where she becomes very anxious and has uncontrollable náusea and vomiting noted.), chest tightness, chest pain, pelvic inflammatory disease, shortness of breath and procedural bleeding.Concomitant products included medroxyprogesterone acetate (depo-provera) from 2011 to 2013 for birth control as well as metoclopramide (reglan) since 2013, ondansetron (zofran) since 2013 and promethazine since 2013.On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2012, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required) and complication of device insertion ("malposition of essure device (lt tube not occluded)/ dr was unable to insert the lt coil/ failure to occlude (close)").In (b)(6) 2012, the patient experienced migraine ("migraines/headaches").In (b)(6) 2012, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)/ cramping with periods / severe abnormal menstrual pain/").In 2013, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant).In (b)(6) 2013, the patient experienced hyperemesis gravidarum (seriousness criterion medically significant).On (b)(6) 2013, the patient experienced vomiting ("vomiting / became pregnant with excessive vomiting").On an unknown date, the patient experienced abdominal pain ("constant cramping/ pain constant mild pain in abdomen/infrequent severe pain in abdomen/ abdominal pain").On an unknown date, the patient experienced heavy menstrual bleeding ("excessive and abnormal bleeding during menstruation/"), dehydration ("she was becoming dehydrated"), nausea ("severe nausea"), abdominal pain lower ("lower abdomen pain constant mild pain since essure, infrequently the pain would become severe in that area") and headache ("headaches").The patient was treated with surgery (salpingectomy (bilateral removal of fallopian tubes), bilateral salpingectomy and elective abortion, d&c).Essure was removed on (b)(6) 2013.At the time of the report, the device dislocation, pelvic pain, hyperemesis gravidarum, pregnancy with contraceptive device, complication of device insertion, heavy menstrual bleeding, dehydration, nausea, vomiting, abdominal pain, abdominal pain lower and headache outcome was unknown and the migraine and dysmenorrhoea had resolved.Pregnancy related information: retrospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was reported as elective abortion.The reporter considered abdominal pain, abdominal pain lower, complication of device insertion, dehydration, device dislocation, dysmenorrhoea, headache, heavy menstrual bleeding, hyperemesis gravidarum, migraine, nausea, pelvic pain, pregnancy with contraceptive device and vomiting to be related to essure.The reporter commented: discussed that essure did not work; pregnancy symptoms were the worst i ever experienced and were threatening the viability of the baby and i was becoming dehydrated & unable to do my normal activities, go to work; discussed removal and permanent tubal ligation.Multiple er visits, hospital visits requiring iv fluid replacements: multiple dr visits trying to get nausea, vomiting, headaches, abdominal pain & cramping under control.These symptoms were unrelieved by prescription medications.These symptoms were severe enough that it was interfering with my ability to work, take care of my other children and my own health.Drs recommended that i terminate the pregnancy and get essure removed.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.3 kg/sqm.Current weight was155 lbs.On (b)(6) 2013, she had on surgical pathology report of fallopian tubes left salpingectomy and right salpingectomy shows benign paratubal cysts.Concerning the injuries reported in this case, the following one was described in patient's medical records: complication of device insertion and pregnacy with contraceptive device.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 29-apr-2021: mr received.Reporter added.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.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('device dislocation in lt tube'), pelvic pain ('pain constant mild pain in pelvis/infrequent severe pain in pelvis/ severe pelvic pain'), hyperemesis gravidarum ('termination of pregnancy due to severe nausea, vomiting/ hyperemesis gravidarium-severe') and pregnancy with contraceptive device ('an unwanted pregnancy/pregnancy (with complications/pregnancy termination)') in a 25-year-old female patient who had essure (batch no.952110) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective" and device monitoring procedure not performed "she did not undergo essure confirmation test".The patient's medical history included live birth on (b)(6) 2012, live birth on (b)(6) 2010, loop electrosurgical excision procedure in 2006, multigravida, gestational hypertension, vaginal haemorrhage, headache, elevated bp, cervical dysplasia, hemorrhoids, parity 2 ((b)(6) 2010 and (b)(6) 2012) and vaginal deliveries), pre-eclampsia and premature birth.Concurrent conditions included body mass index normal, numbness in hand, anxious mood (all pregnancies before have given her similar symptoms where she becomes very anxious and has uncontrollable náusea and vomiting noted.), chest tightness, chest pain, pelvic inflammatory disease, shortness of breath and procedural bleeding.Concomitant products included medroxyprogesterone acetate (depo-provera) from 2011 to 2013 for birth control as well as metoclopramide (reglan) since 2013, ondansetron (zofran) since 2013 and promethazine since 2013.On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2012, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required) and complication of device insertion ("malposition of essure device (lt tube not occluded)/ dr was unable to insert the lt coil/ failure to occlude (close)").In (b)(6) 2012, the patient experienced migraine ("migraines/headaches").In (b)(6) 2012, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)/ cramping with periods/severe abnormal menstrual pain").In 2013, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant).In (b)(6) 2013, the patient experienced hyperemesis gravidarum (seriousness criterion medically significant).On (b)(6) 2013, the patient experienced vomiting ("vomiting/became pregnant with excessive vomiting").On an unknown date, the patient experienced abdominal pain ("constant cramping/pain constant mild pain in abdomen/infrequent severe pain in abdomen/ abdominal pain").On an unknown date, the patient experienced heavy menstrual bleeding ("excessive and abnormal bleeding during menstruation/"), dehydration ("she was becoming dehydrated"), nausea ("severe nausea"), abdominal pain lower ("lower abdomen pain constant mild pain since essure, infrequently the pain would become severe in that area") and headache ("headaches").The patient was treated with surgery (salpingectomy (bilateral removal of fallopian tubes), bilateral salpingectomy and elective abortion, d&c).Essure was removed on (b)(6) 2013.At the time of the report, the device dislocation, pelvic pain, hyperemesis gravidarum, pregnancy with contraceptive device, complication of device insertion, heavy menstrual bleeding, dehydration, nausea, vomiting, abdominal pain, abdominal pain lower and headache outcome was unknown and the migraine and dysmenorrhoea had resolved.Pregnancy related information: retrospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was reported as elective abortion.The reporter considered abdominal pain, abdominal pain lower, complication of device insertion, dehydration, device dislocation, dysmenorrhoea, headache, heavy menstrual bleeding, hyperemesis gravidarum, migraine, nausea, pelvic pain, pregnancy with contraceptive device and vomiting to be related to essure.The reporter commented: discussed that essure did not work; pregnancy symptoms were the worst i ever experienced and were threatening the viability of the baby and i was becoming dehydrated & unable to do my normal activities, go to work; discussed removal and permanent tubal ligation.Multiple er visits, hospital visits requiring iv fluid replacements: multiple dr visits trying to get nausea, vomiting, headaches, abdominal pain & cramping under control.These symptoms were unrelieved by prescription medications.These symptoms were severe enough that it was interfering with my ability to work, take care of my other children and my own health.Drs recommended that i terminate the pregnancy and get essure removed.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.3 kg/sqm.Current weight was155 lbs.On (b)(6) 2013, she had on surgical pathology report of fallopian tubes left salpingectomy and right salpingectomy shows benign paratubal cysts.Concerning the injuries reported in this case, the following one was described in patient's medical records: complication of device insertion and pregnancy with contraceptive device.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 29-apr-2021: mr received.Reporter added.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.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('device dislocation in lt tube'), pelvic pain ('pain constant mild pain in pelvis/infrequent severe pain in pelvis/ severe pelvic pain'), hyperemesis gravidarum ('termination of pregnancy due to severe nausea, vomiting/ hyperemesis gravidarium-severe') and pregnancy with contraceptive device ('an unwanted pregnancy/ pregnancy (with complications/pregnancy termination)') in a 25-year-old female patient who had essure (batch no.952110) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective" and device monitoring procedure not performed "she did not undergo essure confirmation test".The patient's medical history included live birth on (b)(6) 2012, live birth on (b)(6) 2010, loop electrosurgical excision procedure in 2006, multigravida, gestational hypertension, vaginal haemorrhage, headache, elevated bp, cervical dysplasia, hemorrhoids, parity 2 ( (b)(6) 2010 and (b)(6) 2012) and vaginal deliveries), pre-eclampsia and premature birth.Concurrent conditions included body mass index normal, numbness in hand, anxious mood (all pregnancies before have given her similar symptoms where she becomes very anxious and has uncontrollable náusea and vomiting noted.), chest tightness, chest pain, pelvic inflammatory disease, shortness of breath and procedural bleeding.Concomitant products included medroxyprogesterone acetate (depo-provera) from 2011 to 2013 for birth control as well as metoclopramide (reglan) since 2013, ondansetron (zofran) since 2013 and promethazine since 2013.On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2012, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required) and complication of device insertion ("malposition of essure device (lt tube not occluded)/ dr was unable to insert the lt coil/ failure to occlude (close)").In (b)(6) 2012, the patient experienced migraine ("migraines/headaches").In (b)(6) 2012, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)/ cramping with periods/severe abnormal menstrual pain/").In 2013, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant).In (b)(6) 2013, the patient experienced hyperemesis gravidarum (seriousness criterion medically significant).On (b)(6) 2013, the patient experienced vomiting ("vomiting/became pregnant with excessive vomiting").On an unknown date, the patient experienced abdominal pain ("constant cramping/pain constant mild pain in abdomen/infrequent severe pain in abdomen/abdominal pain").On an unknown date, the patient experienced heavy menstrual bleeding ("excessive and abnormal bleeding during menstruation/"), dehydration ("she was becoming dehydrated"), nausea ("severe nausea"), abdominal pain lower ("lower abdomen pain constant mild pain since essure, infrequently the pain would become severe in that area") and headache ("headaches").The patient was treated with surgery (salpingectomy (bilateral removal of fallopian tubes), bilateral salpingectomy and elective abortion, d&c).Essure was removed on (b)(6) 2013.At the time of the report, the device dislocation, pelvic pain, hyperemesis gravidarum, pregnancy with contraceptive device, complication of device insertion, heavy menstrual bleeding, dehydration, nausea, vomiting, abdominal pain, abdominal pain lower and headache outcome was unknown and the migraine and dysmenorrhoea had resolved.Pregnancy related information: retrospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was reported as elective abortion.The reporter considered abdominal pain, abdominal pain lower, complication of device insertion, dehydration, device dislocation, dysmenorrhoea, headache, heavy menstrual bleeding, hyperemesis gravidarum, migraine, nausea, pelvic pain, pregnancy with contraceptive device and vomiting to be related to essure.The reporter commented: discussed that essure did not work; pregnancy symptoms were the worst i ever experienced and were threatening the viability of the baby and i was becoming dehydrated & unable to do my normal activities, go to work; discussed removal and permanent tubal ligation.Multiple er visits, hospital visits requiring iv fluid replacements: multiple dr visits trying to get nausea, vomiting, headaches, abdominal pain & cramping under control.These symptoms were unrelieved by prescription medications.These symptoms were severe enough that it was interfering with my ability to work, take care of my other children and my own health.Drs recommended that i terminate the pregnancy and get essure removed.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.3 kg/sqm.Current weight was155 lbs.On (b)(6) 2013, she had on surgical pathology report of fallopian tubes left salpingectomy and right salpingectomy shows benign paratubal cysts.Lot number: 952110.Manufacture date: 2012-02.Expiration date: 2015-02.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample could not be conducted, as no sample was available.Most recent follow-up information incorporated above includes: on 26-nov-2021: quality safety evaluation of ptc (product technical complaint).We received a lot number in this case.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.
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