| Model Number ESS305 |
| Device Problems
Break (1069); Device Inoperable (1663); Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923); Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
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| Patient Problems
Abdominal Pain (1685); Ectopic Pregnancy (1819); Miscarriage (1962); Joint Dislocation (2374); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Pregnancy (3193); Genital Bleeding (4507); Pregnancy with a Contraceptive Device (4517); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 09/01/2010 |
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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 ("left coil was not seen/migration of essure device"), the first episode of pregnancy with contraceptive device ("1st pregnancy post implant"), abortion spontaneous ("miscarriage") and the second episode of pregnancy with contraceptive device ("2nd pregnancy post implant / pregnancy (no complication)") in a (b)(6) female patient (gravida 7, para 6) who had essure (batch no.689942) 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".The patient's past medical history included gravida ii, parity 6 ((b)(6) 2000, (b)(6) 2003, (b)(6) 2005, (b)(6) 2007, (b)(6) 2010,(b)(6) 2016), smoker and leg operation.Concurrent conditions included body mass index normal and drug hypersensitivity.Concomitant products included medroxyprogesterone acetate (depo-provera).On (b)(6) 2010, the patient had essure inserted.In (b)(6) 2010, the patient experienced device expulsion ("expulsion of essure device").On (b)(6) 2010, 3 months 12 days after insertion of essure, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with abdominal pain.In (b)(6) 2010, the patient experienced abdominal pain upper ("stomach pain").In 2013, the patient experienced the first episode of pregnancy with contraceptive device (seriousness criteria medically significant and intervention required).On (b)(6) 2014, the patient experienced abortion spontaneous (seriousness criteria medically significant and intervention required).In (b)(6) 2015, the patient experienced the second episode of pregnancy with contraceptive device (seriousness criterion medically significant).Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first, second and third trimesters of pregnancy.On (b)(6) 2016, the last episode of pregnancy with contraceptive device had resolved.At the time of the report, the device dislocation, abortion spontaneous, device expulsion and abdominal pain upper outcome was unknown.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abdominal pain upper, abortion spontaneous, device dislocation, device expulsion, the first episode of pregnancy with contraceptive device and the second episode of pregnancy with contraceptive device to be related to essure.The reporter commented: trailing coils: left 1, right 1, the uterus has a somewhat irregular and heterogeneous appearance.She was not advised of any complications from your essure removal procedure.She is currently planning for essure removal diagnostic results (normal ranges are provided in parenthesis if available): body mass index was (b)(6) kg/sqm.On (b)(6) 2010 patient had urine pregnancy test which was negative.On (b)(6) 2010 patient had hysterosalpingogram test resulted in preliminary view of the pelvis was obtained.The essure coils are not definitely seen on today' s exam.After an informed consent was obtained the cervical os was cannulated and contrast was introduced into the uterus.The uterus has a somewhat irregular and heterogeneous appearance.The right fallopian tube is seen on today's exam.The left is not.No free peritoneal spillage is seen.No definite visualization of the essure coils on today' s exam.Opacification of the right fallopian tube with the left fallopian tube not seen.No peritoneal spillage is seen on today's exam.Irregularity to the uterus.This is nonspecific, however, the possibility that this related to fibroids is considered.Confirming the injuries reported in this case, the following one/ones were reported in medical record: device dislocation most recent follow-up information incorporated above includes: on (b)(6) 2018: reporter added,patient historical and concomitant condition added, lot number received, event added as follows:- device dislocation, abdominal pain, abdominal pain uppar, device expulsion.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 retrospective pregnancy case was reported by a lawyer and describes the occurrence of device dislocation ("left coil was not seen/migration of essure device /migration of essure device-location of device"), device breakage ("device breakage"), pregnancy with contraceptive device ("1st pregnancy post implant") and abortion spontaneous ("miscarriage /pregnancy (stillbirth or miscarriage) miscarriage") in a 28-year-old female patient (gravida 6, para 5) who had essure (batch no.689942) 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".The patient's past medical history included multigravida, parity 5 ((b)(6) 2000, (b)(6) 2003, (b)(6) 2005, (b)(6) 2007, (b)(6) 2010), smoker and leg operation.Concurrent conditions included body mass index normal and penicillin allergy.Concomitant products included medroxyprogesterone acetate (depo-provera) and paracetamol (acetaminophen) since (b)(6) 2010.On (b)(6) 2010, the patient had essure inserted.In (b)(6) 2010, the patient experienced device expulsion ("expulsion of essure device").On (b)(6) 2010, 3 months 12 days after insertion of essure, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with abdominal pain.In (b)(6) 2010, the patient experienced device breakage (seriousness criteria medically significant and intervention required), abdominal pain upper ("stomach pain") and pelvic pain ("pelvic pain").In 2013, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).On (b)(6) 2014, the patient experienced abortion spontaneous (seriousness criterion medically significant).Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first trimester of pregnancy.The patient was treated with surgery.At the time of the report, the device dislocation, device breakage, pregnancy with contraceptive device, abortion spontaneous, device expulsion, abdominal pain upper and pelvic pain outcome was unknown.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abdominal pain upper, abortion spontaneous, device breakage, device dislocation, device expulsion, pelvic pain and pregnancy with contraceptive device to be related to essure.The reporter commented: trailing coils: left 1, right 1, the uterus has a somewhat irregular and heterogeneous appearance.She was not advised of any complications from your essure removal procedure.She is currently planning for essure removal.2nd pregnancy post implant / pregnancy (no complication), for second pregnancy new case was created.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 18.3 kg/sqm.On (b)(6) 2010 patient had urine pregnancy test which was negative.On (b)(6) 2010 patient had hysterosalpingogrm test resulted in preliminary view of the pelvis was obtained.The essure coils are not definitely seen on today' s exam.After an informed consent was obtained the cervical os was cannulated and contrast was introduced into the uterus.The uterus has a somewhat irregular and heterogeneous appearance.The right fallopian tube is seen on today's exam.The left is not.No free peritoneal spillage is seen.No definite visualization of the essure coils ontoday' s exam.Opacification of the right fallopian tube with the left fallopian tube not seen.No peritoneal spillage is seen on today's exam.Irregularity to the uterus.This is nonspecific, however, the possibility that this related to fibroids is considered.Confirming the injuries reported in this case, the following one/ones were reported in medical record: device dislocation most recent follow-up information incorporated above includes: on 17-may-2018: pfs received.Reporter was added.Patient¿s concomitant drug was added.Device breakage and pelvic pain were added as events.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 ("left coil was not seen/migration of essure device /migration of essure device-location of device"), device breakage ("device breakage"), pregnancy with contraceptive device ("1st pregnancy post implant"), abortion spontaneous ("miscarriage /pregnancy (stillbirth or miscarriage) miscarriage"), genital haemorrhage ("bleeding") and device expulsion ("expulsion of essure device/migration of essure device location of device: uterus") in a 28-year-old female patient who had essure (batch no.689942) 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".The patient's medical history included multigravida, parity 5 ((b)(6)2000, (b)(6)2003, (b)(6)2005, (b)(6)2007, (b)(6)2010), smoker and leg operation.Concurrent conditions included body mass index normal and penicillin allergy.Concomitant products included ibuprofen, medroxyprogesterone acetate (depo-provera) and paracetamol (acetaminophen) since june 2010.On (b)(6)2010, the patient had essure inserted.On (b)(6)2010, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)"), 1 month 23 days after insertion of essure.In september 2010, the patient experienced device expulsion (seriousness criteria medically significant and intervention required).On(b)(6)2010, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with abdominal pain.In october 2010, the patient experienced device breakage (seriousness criteria medically significant and intervention required), abdominal pain upper ("stomach pain") and pelvic pain ("pelvic pain").In 2013, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant).On (b)(6)2014, the patient experienced abortion spontaneous (seriousness criterion medically significant).On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), vaginal haemorrhage ("abnormal vaginal bleeding"), menorrhagia ("menorrhagia"), depression ("depression"), anxiety ("mental anguish"), dysmenorrhoea ("dysmenorrhea") and back pain ("back pain").The patient was treated with surgery ((b)(6)2016 (surgical removal of coil(s)).Essure was removed on (b)(6)2016.At the time of the report, the device dislocation, device breakage, pregnancy with contraceptive device, abortion spontaneous, device expulsion, abdominal pain upper, vaginal haemorrhage, menorrhagia, depression, anxiety, dysmenorrhoea and dyspareunia outcome was unknown and the genital haemorrhage, pelvic pain and back pain had resolved.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 6, para 5.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 spontaneous abortion.The reporter considered abdominal pain upper, abortion spontaneous, anxiety, back pain, depression, device breakage, device dislocation, device expulsion, dysmenorrhoea, dyspareunia, genital haemorrhage, menorrhagia, pelvic pain, pregnancy with contraceptive device and vaginal haemorrhage to be related to essure.The reporter commented: trailing coils: left 1, right 1, the uterus has a somewhat irregular and heterogeneous appearance.She was not advised of any complications from your essure removal procedure.She is currently planning for essure removal 2nd pregnancy post implant / pregnancy (no complication), for second pregnancy new case was created.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 18.3 kg/sqm.Hysterosalpingogram - on (b)(6)2010: results: expulsion of essure device resulted in preliminary view of the pelvis was obtained.The essure coils are not definitely seen on today' s exam.After an informed consent was obtained the cervical os was cannulated and contrast was introduced into the uterus.The uterus has a somewhat irregular and heterogeneous appearance.The right fallopian tube is seen on today's exam.The left is not.No free peritoneal spillage is seen.No definite visualization of the essure coils ontoday' s exam.Opacification of the right fallopian tube with the left fallopian tube not seen.No peritoneal spillage is seen on today's exam.Irregularity to the uterus.This is nonspecific, however, the possibility that this related to fibroids is considered.Pregnancy test urine - on (b)(6)2010: negative.Confirming the injuries reported in this case, the following one/ones were reported in medical record: device dislocation quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6)2018: pfs received: events vaginal bleeding, menorrhagia, depression, anxiety, dysmenorrhea, dyspareunia, back pain, bleeding added.Outcome of event pains, bleeding added as recovered.Concomitant medication added 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.
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Manufacturer Narrative
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This retrospective pregnancy case was reported by a lawyer and describes the occurrence of device dislocation ("left coil was not seen/migration of essure device /migration of essure device-location of device"), device breakage ("device breakage"), pregnancy with contraceptive device ("1st pregnancy post implant") and abortion spontaneous ("miscarriage /pregnancy (stillbirth or miscarriage) miscarriage") in a 28-year-old female patient (gravida 6, para 5) who had essure (batch no.689942) 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".The patient's past medical history included multigravida, parity 5 ((b)(6) 2000, (b)(6) 2003, (b)(6) 2005, (b)(6) 2007, (b)(6) 2010), smoker and leg operation.Concurrent conditions included body mass index normal and penicillin allergy.Concomitant products included medroxyprogesterone acetate (depo-provera) and paracetamol (acetaminophen) since (b)(6) 2010.On (b)(6) 2010, the patient had essure inserted.In (b)(6) 2010, the patient experienced device expulsion ("expulsion of essure device").On (b)(6) 2010, 3 months 12 days after insertion of essure, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with abdominal pain.In (b)(6) 2010, the patient experienced device breakage (seriousness criteria medically significant and intervention required), abdominal pain upper ("stomach pain") and pelvic pain ("pelvic pain").In 2013, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).On (b)(6) 2014, the patient experienced abortion spontaneous (seriousness criterion medically significant).Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first trimester of pregnancy.The patient was treated with surgery.At the time of the report, the device dislocation, device breakage, pregnancy with contraceptive device, abortion spontaneous, device expulsion, abdominal pain upper and pelvic pain outcome was unknown.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abdominal pain upper, abortion spontaneous, device breakage, device dislocation, device expulsion, pelvic pain and pregnancy with contraceptive device to be related to essure.The reporter commented: trailing coils: left 1, right 1, the uterus has a somewhat irregular and heterogeneous appearance.She was not advised of any complications from your essure removal procedure.She is currently planning for essure removal.2nd pregnancy post implant / pregnancy (no complication), for second pregnancy new case was created.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 18.3 kg/sqm.On (b)(6) 2010 patient had urine pregnancy test which was negative.On (b)(6) 2010 patient had hysterosalpingogrm test resulted in preliminary view of the pelvis was obtained.The essure coils are not definitely seen on today' s exam.After an informed consent was obtained the cervical os was cannulated and contrast was introduced into the uterus.The uterus has a somewhat irregular and heterogeneous appearance.The right fallopian tube is seen on today's exam.The left is not.No free peritoneal spillage is seen.No definite visualization of the essure coils on today' s exam.Opacification of the right fallopian tube with the left fallopian tube not seen.No peritoneal spillage is seen on today's exam.Irregularity to the uterus.This is nonspecific, however, the possibility that this related to fibroids is considered.Confirming the injuries reported in this case, the following one/ones were reported in medical record: device dislocation.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 17-jul-2018: quality safety evaluation of ptc.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 ('left coil was not seen/migration of essure device /migration of essure device-location of device'), device breakage ('device breakage'), pregnancy with contraceptive device ('1st pregnancy post implant'), abortion spontaneous ('miscarriage /pregnancy (stillbirth or miscarriage) miscarriage'), genital haemorrhage ('bleeding') and device expulsion ('expulsion of essure device/migration of essure device location of device: uterus') in a 28-year-old female patient who had essure (batch no.689942) 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".The patient's medical history included multigravida, parity 5 ((b)(6) 2000, (b)(6) 2003, (b)(6) 2005, (b)(6) 2007, (b)(6) 2010), smoker and leg operation.Concurrent conditions included body mass index normal and penicillin allergy.Concomitant products included ibuprofen, medroxyprogesterone acetate (depo-provera) and paracetamol (acetaminophen) since (b)(6) 2010.On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2010, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)"), 1 month 23 days after insertion of essure.In (b)(6) 2010, the patient experienced device expulsion (seriousness criteria medically significant and intervention required).On (b)(6) 2010, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with abdominal pain.In (b)(6) 2010, the patient experienced device breakage (seriousness criteria medically significant and intervention required), abdominal pain upper ("stomach pain") and pelvic pain ("pelvic pain").In 2013, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant).On (b)(6) 2014, the patient experienced abortion spontaneous (seriousness criterion medically significant).On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), vaginal haemorrhage ("abnormal vaginal bleeding"), menorrhagia ("menorrhagia"), depression ("depression"), anxiety ("mental anguish"), dysmenorrhoea ("dysmenorrhea") and back pain ("back pain").The patient was treated with surgery ((b)(6) 2016 (surgical removal of coil(s)).Essure was removed on (b)(6) 2016.At the time of the report, the device dislocation, device breakage, pregnancy with contraceptive device, abortion spontaneous, device expulsion, abdominal pain upper, vaginal haemorrhage, menorrhagia, depression, anxiety, dysmenorrhoea and dyspareunia outcome was unknown and the genital haemorrhage, pelvic pain and back pain had resolved.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 6, para 5.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 spontaneous abortion.The reporter considered abdominal pain upper, abortion spontaneous, anxiety, back pain, depression, device breakage, device dislocation, device expulsion, dysmenorrhoea, dyspareunia, genital haemorrhage, menorrhagia, pelvic pain, pregnancy with contraceptive device and vaginal haemorrhage to be related to essure.The reporter commented: trailing coils: left 1, right 1, the uterus has a somewhat irregular and heterogeneous appearance.She was not advised of any complications from your essure removal procedure.She is currently planning for essure removal.2nd pregnancy post implant / pregnancy (no complication), for second pregnancy new case was created.Patient has received treatment for event migration.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 18.3 kg/sqm.Hysterosalpingogram - on (b)(6) 2010: results: expulsion of essure device resulted in preliminary view of the pelvis was obtained.The essure coils are not definitely seen on today' s exam.After an informed consent was obtained the cervical os was cannulated and contrast was introduced into the uterus.The uterus has a somewhat irregular and heterogeneous appearance.The right fallopian tube is seen on today's exam.The left is not.No free peritoneal spillage is seen.No definite visualization of the essure coils ontoday' s exam.Opacification of the right fallopian tube with the left fallopian tube not seen.No peritoneal spillage is seen on today's exam.Irregularity to the uterus.This is nonspecific, however, the possibility that this related to fibroids is considered.Pregnancy test urine - on (b)(6) 2010: negative.Confirming the injuries reported in this case, the following one/ones were reported in medical record: device dislocation.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 22-mar-2021: mr received.Reporter information was added.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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('left coil was not seen/migration of essure device /migration of essure device-location of device'), device breakage ('device breakage'), pregnancy with contraceptive device ('1st pregnancy post implant'), abortion spontaneous ('miscarriage /pregnancy (stillbirth or miscarriage) miscarriage'), genital haemorrhage ('bleeding') and device expulsion ('expulsion of essure device/migration of essure device location of device: uterus') in a 28-year-old female patient who had essure (batch no.689942) 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".The patient's medical history included multigravida, parity 5 ( (b)(6) 2000, (b)(6) 2003, (b)(6) 2005, (b)(6) 2007, (b)(6) 2010), smoker and leg operation.Concurrent conditions included body mass index normal and penicillin allergy.Concomitant products included ibuprofen, medroxyprogesterone acetate (depo-provera) and paracetamol (acetaminophen) since (b)(6) 2010.On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2010, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)"), 1 month 23 days after insertion of essure.In (b)(6) 2010, the patient experienced device expulsion (seriousness criteria medically significant and intervention required).On (b)(6) 2010, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with abdominal pain.In (b)(6) 2010, the patient experienced device breakage (seriousness criteria medically significant and intervention required), abdominal pain upper ("stomach pain") and pelvic pain ("pelvic pain").In 2013, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant).On (b)(6) 2014, the patient experienced abortion spontaneous (seriousness criterion medically significant).On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), vaginal haemorrhage ("abnormal vaginal bleeding"), menorrhagia ("menorrhagia"), depression ("depression"), anxiety ("mental anguish"), dysmenorrhoea ("dysmenorrhea") and back pain ("back pain").The patient was treated with surgery ((b)(6) 2016 (surgical removal of coil(s)).Essure was removed on (b)(6) 2016.At the time of the report, the device dislocation, device breakage, pregnancy with contraceptive device, abortion spontaneous, device expulsion, abdominal pain upper, vaginal haemorrhage, menorrhagia, depression, anxiety, dysmenorrhoea and dyspareunia outcome was unknown and the genital haemorrhage, pelvic pain and back pain had resolved.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 6, para 5.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 spontaneous abortion.The reporter considered abdominal pain upper, abortion spontaneous, anxiety, back pain, depression, device breakage, device dislocation, device expulsion, dysmenorrhoea, dyspareunia, genital haemorrhage, menorrhagia, pelvic pain, pregnancy with contraceptive device and vaginal haemorrhage to be related to essure.The reporter commented: trailing coils: left 1, right 1, the uterus has a somewhat irregular and heterogeneous appearance.She was not advised of any complications from your essure removal procedure.She is currently planning for essure removal.2nd pregnancy post implant / pregnancy (no complication), for second pregnancy new case was created.Patient has received treatment for event migration.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 18.3 kg/sqm.Hysterosalpingogram - on (b)(6) 2010: results: expulsion of essure device resulted in preliminary view of the pelvis was obtained.The essure coils are not definitely seen on today' s exam.After an informed consent was obtained the cervical os was cannulated and contrast was introduced into the uterus.The uterus has a somewhat irregular and heterogeneous appearance.The right fallopian tube is seen on today's exam.The left is not.No free peritoneal spillage is seen.No definite visualization of the essure coils ontoday' s exam.Opacification of the right fallopian tube with the left fallopian tube not seen.No peritoneal spillage is seen on today's exam.Irregularity to the uterus.This is nonspecific, however, the possibility that this related to fibroids is considered.Pregnancy test urine - on (b)(6) 2010: negative.Confirming the injuries reported in this case, the following one/ones were reported in medical record: device dislocation quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 22-mar-2021: mr received.Reporter information was added.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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('left coil was not seen/migration of essure device /migration of essure device-location of device'), device breakage ('device breakage'), pregnancy with contraceptive device ('1st pregnancy post implant'), abortion spontaneous ('miscarriage /pregnancy (stillbirth or miscarriage) miscarriage'), genital haemorrhage ('bleeding') and device expulsion ('expulsion of essure device/migration of essure device location of device: uterus') in a 28-year-old female patient who had essure (batch no.689942) 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".The patient's medical history included multigravida, parity 5 ((b)(6) 2000, (b)(6) 2003, (b)(6) 2005, (b)(6) 2007, (b)(6) 2010), smoker and leg operation.Concurrent conditions included body mass index normal and penicillin allergy.Concomitant products included ibuprofen, medroxyprogesterone acetate (depo-provera) and paracetamol (acetaminophen) since (b)(6) 2010.On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2010, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)"), 1 month 23 days after insertion of essure.In (b)(6) 2010, the patient experienced device expulsion (seriousness criteria medically significant and intervention required).On (b)(6) 2010, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with abdominal pain.In (b)(6) 2010, the patient experienced device breakage (seriousness criteria medically significant and intervention required), abdominal pain upper ("stomach pain") and pelvic pain ("pelvic pain").In 2013, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant).On (b)(6) 2014, the patient experienced abortion spontaneous (seriousness criterion medically significant).On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), vaginal haemorrhage ("abnormal vaginal bleeding"), menorrhagia ("menorrhagia"), depression ("depression"), anxiety ("mental anguish"), dysmenorrhoea ("dysmenorrhea") and back pain ("back pain").The patient was treated with surgery ((b)(6) 2016 (surgical removal of coil(s)).Essure was removed on (b)(6) 2016.At the time of the report, the device dislocation, device breakage, pregnancy with contraceptive device, abortion spontaneous, device expulsion, abdominal pain upper, vaginal haemorrhage, menorrhagia, depression, anxiety, dysmenorrhoea and dyspareunia outcome was unknown and the genital haemorrhage, pelvic pain and back pain had resolved.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 6, para 5.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 spontaneous abortion.The reporter considered abdominal pain upper, abortion spontaneous, anxiety, back pain, depression, device breakage, device dislocation, device expulsion, dysmenorrhoea, dyspareunia, genital haemorrhage, menorrhagia, pelvic pain, pregnancy with contraceptive device and vaginal haemorrhage to be related to essure.The reporter commented: trailing coils: left 1, right 1, the uterus has a somewhat irregular and heterogeneous appearance.She was not advised of any complications from your essure removal procedure.She is currently planning for essure removal.2nd pregnancy post implant / pregnancy (no complication), for second pregnancy new case was created.Patient has received treatment for event migration.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 18.3 kg/sqm.Hysterosalpingogram - on (b)(6) 2010: results: expulsion of essure device resulted in preliminary view of the pelvis was obtained.The essure coils are not definitely seen on today' s exam.After an informed consent was obtained the cervical os was cannulated and contrast was introduced into the uterus.The uterus has a somewhat irregular and heterogeneous appearance.The right fallopian tube is seen on today's exam.The left is not.No free peritoneal spillage is seen.No definite visualization of the essure coils ontoday' s exam.Opacification of the right fallopian tube with the left fallopian tube not seen.No peritoneal spillage is seen on today's exam.Irregularity to the uterus.This is nonspecific, however, the possibility that this related to fibroids is considered.Pregnancy test urine - on (b)(6) 2010: negative.Confirming the injuries reported in this case, the following one/ones were reported in medical record: device dislocation.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 22-mar-2021: mr received.Reporter information was added.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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('left coil was not seen/migration of essure device /migration of essure device-location of device'), device breakage ('device breakage'), pregnancy with contraceptive device ('1st pregnancy post implant'), abortion spontaneous ('miscarriage /pregnancy (stillbirth or miscarriage) miscarriage'), genital haemorrhage ('bleeding') and device expulsion ('expulsion of essure device/migration of essure device location of device: uterus') in a 28-year-old female patient who had essure (batch no.689942) 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".The patient's medical history included multigravida, parity 5 ( (b)(6) 2000, (b)(6) 2003, (b)(6) 2005, (b)(6) 2007, (b)(6) 2010), smoker and leg operation.Concurrent conditions included body mass index normal and penicillin allergy.Concomitant products included ibuprofen, medroxyprogesterone acetate (depo-provera) and paracetamol (acetaminophen) since (b)(6) 2010.On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2010, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)"), 1 month 23 days after insertion of essure.In (b)(6) 2010, the patient experienced device expulsion (seriousness criteria medically significant and intervention required).On (b)(6) 2010, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with abdominal pain.In (b)(6) 2010, the patient experienced device breakage (seriousness criteria medically significant and intervention required), abdominal pain upper ("stomach pain") and pelvic pain ("pelvic pain").In 2013, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant).On (b)(6) 2014, the patient experienced abortion spontaneous (seriousness criterion medically significant).On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), vaginal haemorrhage ("abnormal vaginal bleeding"), heavy menstrual bleeding ("menorrhagia"), depression ("depression"), anxiety ("mental anguish"), dysmenorrhoea ("dysmenorrhea") and back pain ("back pain").The patient was treated with surgery ((b)(6) 2016 (surgical removal of coil(s)).Essure was removed on (b)(6) 2016.At the time of the report, the device dislocation, device breakage, pregnancy with contraceptive device, abortion spontaneous, device expulsion, abdominal pain upper, vaginal haemorrhage, heavy menstrual bleeding, depression, anxiety, dysmenorrhoea and dyspareunia outcome was unknown and the genital haemorrhage, pelvic pain and back pain had resolved.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 6, para 5.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 spontaneous abortion.The reporter considered abdominal pain upper, abortion spontaneous, anxiety, back pain, depression, device breakage, device dislocation, device expulsion, dysmenorrhoea, dyspareunia, genital haemorrhage, heavy menstrual bleeding, pelvic pain, pregnancy with contraceptive device and vaginal haemorrhage to be related to essure.The reporter commented: trailing coils: left 1, right 1, the uterus has a somewhat irregular and heterogeneous appearance.She was not advised of any complications from your essure removal procedure.She is currently planning for essure removal.2nd pregnancy post implant / pregnancy (no complication), for second pregnancy new case was created.Patient has received treatment for event migration.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 18.3 kg/sqm.Hysterosalpingogram - on (b)(6) 2010: results: expulsion of essure device resulted in preliminary view of the pelvis was obtained.The essure coils are not definitely seen on today' s exam.After an informed consent was obtained the cervical os was cannulated and contrast was introduced into the uterus.The uterus has a somewhat irregular and heterogeneous appearance.The right fallopian tube is seen on today's exam.The left is not.No free peritoneal spillage is seen.No definite visualization of the essure coils on today' s exam.Opacification of the right fallopian tube with the left fallopian tube not seen.No peritoneal spillage is seen on today's exam.Irregularity to the uterus.This is nonspecific, however, the possibility that this related to fibroids is considered.Pregnancy test urine - on (b)(6) 2010: negative.Lot number:689942: manufacturing date: 2009-11, expiration date: 2012-11.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 6-oct-2021: quality safety evaluation of 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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