| Model Number ESS205 |
| Device Problems
Separation Failure (2547); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Migration (4003)
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| Patient Problems
Pain (1994); Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 01/01/2006 |
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Event Type
Injury
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Event Description
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain/pelvic area") and pregnancy with contraceptive device ("pregnancy (with complications)") in a (b)(6) year-old female patient who had essure (ess205) 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 4 (on ((b)(6) 1991, (b)(6) 1994, (b)(6) 2005, (b)(6) 2007).), miscarriage in (b)(6) , c-section (emergency c-section with last pregnancy after essure.) and depression from 2003 to 2018.Concomitant products included sertraline hydrochloride (zoloft) from 2003 to 2018.In (b)(6) 2005, the patient had essure (ess205) inserted.In (b)(6) 2006, the patient experienced flank pain.In 2006, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).In (b)(6) 2006, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant).In (b)(6) 2008, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia);"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia);"), dysmenorrhoea ("dysmenorrhea cramping);") and dyspareunia ("dyspareunia (painful sexual intercourse)").In 2008, the patient was found to have cervix carcinoma ("tumor/teratoma/cancer type: cervical") and uterine cancer ("tumor/teratoma/cancer type: uterine") and experienced vaginal discharge ("vaginal discharge.").The patient was treated with surgery (hysterectomy with bilateral salpingo-oophorectomy).Essure (ess205) was removed on (b)(6) 2008.At the time of the report, the pelvic pain, vaginal haemorrhage, menorrhagia, cervix carcinoma, uterine cancer and vaginal discharge had resolved and the pregnancy with contraceptive device, dysmenorrhoea, dyspareunia and flank pain outcome was unknown.Pregnancy related information: prospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure (ess205) occurred during the first trimester.The pregnancy outcome was not reported.The reporter considered cervix carcinoma, dysmenorrhoea, dyspareunia, flank pain, menorrhagia, pelvic pain, pregnancy with contraceptive device, uterine cancer, vaginal discharge and vaginal haemorrhage to be related to essure (ess205).Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound scan vagina - on an unknown date: results: total bilateral occlusion.Amendment: the report was amended on (b)(6) 2019 for the following reason: intervention required field was ticked for the event pain/pelvic area.No new follow-up information was received from the reporter.No lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances 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 ("coils right unable / failed on left side"), pelvic pain ("pain/pelvic area") and pregnancy with contraceptive device ("pregnancy (with complications)") in a 37-year-old female patient who had essure (ess205) (batch no.12277837) 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 4 (on ((b)(6) 1991, (b)(6) 1994, (b)(6) 2005, (b)(6) 2007).), miscarriage in 1987, c-section (emergency c-section with last pregnancy after essure.), depression from 2003 to 2018, vaginal delivery (vaginal delivery: (b)(6) 2005.) on (b)(6) 2005 and necrosis.Concomitant products included sertraline hydrochloride (zoloft) from 2003 to 2018.On (b)(6) 2005, the patient had essure (ess205) inserted.On (b)(6) 2006, the patient experienced flank pain ("flank pain").In 2006, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On (b)(6) 2006, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant).On (b)(6) 2008, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia);"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia);"), dysmenorrhoea ("dysmenorrhea cramping);") and dyspareunia ("dyspareunia (painful sexual intercourse)").In 2008, the patient was found to have cervix carcinoma ("tumor / teratoma / cancer type: cervical") and uterine cancer ("tumor / teratoma / cancer type: uterine") and experienced vaginal discharge ("vaginal discharge.").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).The patient was treated with surgery (hysterectomy with bilateral salpingo-oophorectomy and hysterectomy with bilateral salpingo-oopherectomy, dilatation and curettage).Essure (ess205) was removed on (b)(6) 2008.At the time of the report, the device dislocation, pregnancy with contraceptive device, dysmenorrhoea, dyspareunia and flank pain outcome was unknown and the pelvic pain, vaginal haemorrhage, menorrhagia, cervix carcinoma, uterine cancer and vaginal discharge had resolved.Pregnancy related information: prospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure (ess205) occurred during the first trimester.The pregnancy outcome was not reported.The reporter considered cervix carcinoma, device dislocation, dysmenorrhoea, dyspareunia, flank pain, menorrhagia, pelvic pain, pregnancy with contraceptive device, uterine cancer, vaginal discharge and vaginal haemorrhage to be related to essure (ess205).The reporter commented: coils right unable, left coils showing.The first attempt to place the essure device on the patient's left side resulted in difficulty in inserting the device.Essure device on the left side resulted in the coil being released, but then it would not separate from the insertion device.Therefore the coil was retracted along with the insertion device.Diagnostic results (normal ranges are provided in parenthesis if available): pregnancy test urine on (b)(6) 2005: negative.Ultrasound scan vagina - on an unknown date: results: total bilateral occlusion.Concerning the injuries reported in this case, the following one/ones were reported via medical records: device dislocation.Most recent follow-up information incorporated above includes: on (b)(6) 2019: medical records received: reporters were added.Patient race was added.Lot number was added.Event device dislocation was added.Medical history was added.Lab data was added.Reporter causality comments were added.Auto-narrative supplement was added.Insertion date was updated.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 spontaneous case was reported by a lawyer and describes the occurrence of complication of device insertion ("coils right unable / failed on left side"), pelvic pain ("pain/pelvic area") and pregnancy with contraceptive device ("pregnancy (with complications)") in a 37-year-old female patient who had essure (ess205) (batch no.12277837-inv) 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 4 (on ((b)(6) 1991, (b)(6) 1994, (b)(6) 2005, (b)(6) 2007).), miscarriage in 1987, c-section (emergency c-section with last pregnancy after essure.), depression from 2003 to 2018, vaginal delivery (vaginal delivery: (b)(6) 2005.) on (b)(6) 2005 and necrosis nos.Concomitant products included sertraline hydrochloride (zoloft) from 2003 to 2018.On (b)(6) 2005, the patient had essure (ess205) inserted.In (b)(6) 2006, the patient experienced flank pain ("flank pain").In 2006, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).In (b)(6) 2006, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant).In (b)(6) 2008, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia);"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia);"), dysmenorrhoea ("dysmenorrhea cramping);") and dyspareunia ("dyspareunia (painful sexual intercourse)").In 2008, the patient was found to have cervix carcinoma ("tumor / teratoma / cancer type: cervical") and uterine cancer ("tumor / teratoma / cancer type: uterine") and experienced vaginal discharge ("vaginal discharge.").On an unknown date, the patient experienced complication of device insertion (seriousness criteria medically significant and intervention required).The patient was treated with surgery (hysterectomy with bilateral salpingo-oophorectomy and hysterectomy with bilateral salpingo-oopherectomy, dilatation and curettage).Essure (ess205) was removed on (b)(6) 2008.At the time of the report, the complication of device insertion, pregnancy with contraceptive device, dysmenorrhoea, dyspareunia and flank pain outcome was unknown and the pelvic pain, vaginal haemorrhage, menorrhagia, cervix carcinoma, uterine cancer and vaginal discharge had resolved.Pregnancy related information: prospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure (ess205) occurred during the first trimester.The pregnancy outcome was not reported.The reporter considered cervix carcinoma, complication of device insertion, dysmenorrhoea, dyspareunia, flank pain, menorrhagia, pelvic pain, pregnancy with contraceptive device, uterine cancer, vaginal discharge and vaginal haemorrhage to be related to essure (ess205).The reporter commented: coils right unable, left coils showing.The first attempt to place the essure device on the patient's left side resulted in difficulty in inserting the device.Essure device on the left side resulted in the coil being released, but then it would not separate from the insertion device.Therefore the coil was retracted along with the insertion device.Diagnostic results (normal ranges are provided in parenthesis if available): pregnancy test urine on (b)(6) : negative.Ultrasound scan vagina on an unknown date: results: total bilateral occlusion.Concerning the injuries reported in this case, the following one/ones were reported via medical records: device dislocation.Lot number reported 12277837 is invalid.Most recent follow-up information incorporated above includes: on 16-jan-2019: update of information (batch is invalid).Incident: no valid lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances 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 ("coils right unable / failed on left side"), pelvic pain ("pain/pelvic area"), uterine cancer ("tumor / teratoma / cancer type: uterine"), cervix carcinoma ("tumor / teratoma / cancer type: cervical") and pregnancy with contraceptive device ("pregnancy (with complications)") in a 37-year-old female patient who had essure (ess205) (batch no.12277837-inv) 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 4 (on ((b)(6) 1991, (b)(6) 1994, (b)(6) 2005, (b)(6) 2007).), miscarriage in 1987, c-section (emergency c-section with last pregnancy after essure.), depression from 2003 to 2018, vaginal delivery (vaginal delivery: (b)(6) 2005.) on (b)(6) 2005 and necrosis nos.Concurrent conditions included nausea, vomiting, hives, diabetes, depression, anemia, tobacco abuse, deep vein thrombosis, dysfunctional uterine bleeding and cervical dysplasia.Concomitant products included naproxen and sertraline hydrochloride (zoloft) from 2003 to 2018.On (b)(6) 2005, the patient had essure (ess205) inserted.In (b)(6) 2006, the patient experienced flank pain ("flank pain").In 2006, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).In (b)(6) 2006, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant).In (b)(6) 2008, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia);"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia);"), dysmenorrhoea ("dysmenorrhea cramping);") and dyspareunia ("dyspareunia (painful sexual intercourse)").In 2008, the patient was found to have uterine cancer (seriousness criterion medically significant) and cervix carcinoma (seriousness criterion medically significant) and experienced vaginal discharge ("vaginal discharge.").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) and urinary tract disorder ("urinary problems").The patient was treated with surgery (hysterectomy with bilateral salpingo-oophorectomy and hysterectomy with bilateral salpingo-oophorectomy, dilatation and curettage).Essure (ess205) was removed on (b)(6) 2010.At the time of the report, the device dislocation, pregnancy with contraceptive device, dysmenorrhoea, dyspareunia, flank pain and urinary tract disorder outcome was unknown and the pelvic pain, uterine cancer, cervix carcinoma, vaginal haemorrhage, menorrhagia and vaginal discharge had resolved.Pregnancy related information: prospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure (ess205) occurred during the first trimester.The pregnancy outcome was not reported.The reporter considered cervix carcinoma, device dislocation, dysmenorrhoea, dyspareunia, flank pain, menorrhagia, pelvic pain, pregnancy with contraceptive device, urinary tract disorder, uterine cancer, vaginal discharge and vaginal haemorrhage to be related to essure (ess205).The reporter commented: coils right unable, left coils showing.The first attempt to place the essure device on the patient's left side resulted in difficulty in inserting the device.Essure device on the left side resulted in the coil being released, but then it would not separate from the insertion device.Therefore the coil was retracted along with the insertion device.Discrepancy noted as per pfs dated 20-feb-19, date of insertion noted (b)(6) 2010, previously it was reported (b)(6) 2008.Diagnostic results (normal ranges are provided in parenthesis if available): pregnancy test urine - on (b)(6) 2005: negative.Ultrasound scan vagina - on an unknown date: results: total bilateral occlusion.Concerning the injuries reported in this case, the following one/ones were reported via medical records: device dislocation.Lot number reported 12277837 is invalid.Most recent follow-up information incorporated above includes: on 25-feb-2019: pfs and medical record received.Reporter's information was added.Date of removal was updated.Added event urinary problems.Concomitant condition, concomitant drug were added.Incident: no valid lot number or device sample was received in this case.We will conduct a review of our complaint records and other non-conformances 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 ('coils right unable / failed on left side'), pelvic pain ('pain/pelvic area'), uterine cancer ('tumor / teratoma / cancer type: uterine'), cervix carcinoma ('tumor / teratoma / cancer type: cervical') and pregnancy with contraceptive device ('pregnancy (with complications)') in a 37-year-old female patient who had essure (ess205) (batch no.12277837) 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 vaginal delivery (vaginal delivery: (b)(6) 2005.) on (b)(6) 2005, depression from 2003 to 2018, miscarriage in 1987, multigravida, parity 4 (on ((b)(6) 1991, (b)(6) 1994, (b)(6) 2005, (b)(6) 2007).), c-section (emergency c-section with last pregnancy after essure.), necrosis nos, dizzy and chills.Previously administered products included for an unreported indication: effexor.Concurrent conditions included nausea, vomiting, hives, diabetes, depression, anemia, tobacco abuse, deep vein thrombosis, dysfunctional uterine bleeding, cervical dysplasia and sleep apnea.Concomitant products included medroxyprogesterone acetate (depo provera), naproxen and sertraline hydrochloride (zoloft) from 2003 to 2018.On (b)(6) 2005, the patient had essure (ess205) inserted.In (b)(6) 2005, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)").In (b)(6) 2006, the patient experienced flank pain ("flank pain").In 2006, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).In (b)(6) 2006, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant).In (b)(6) 2008, the patient was found to have uterine cancer (seriousness criterion medically significant) and cervix carcinoma (seriousness criterion medically significant).In (b)(6) 2008, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia);"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia);"), dysmenorrhoea ("dysmenorrhea cramping);") and vaginal discharge ("vaginal discharge.").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) and dysuria ("urinary problems").The patient was treated with surgery (hysterectomy with bilateral salpingo-oopherectomy and hysterectomy with bilateral salpingo-oopherectomy, dilatation and curettage).Essure (ess205) was removed on (b)(6) 2010.At the time of the report, the device dislocation, pregnancy with contraceptive device, dysmenorrhoea, dyspareunia, flank pain and dysuria outcome was unknown and the pelvic pain, uterine cancer, cervix carcinoma, vaginal haemorrhage, menorrhagia and vaginal discharge had resolved.Pregnancy related information: prospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure (ess205) occurred during the first trimester.The pregnancy outcome was not reported.The reporter considered cervix carcinoma, device dislocation, dysmenorrhoea, dyspareunia, dysuria, flank pain, menorrhagia, pelvic pain, pregnancy with contraceptive device, uterine cancer, vaginal discharge and vaginal haemorrhage to be related to essure (ess205).The reporter commented: coils right unable, left coils showing.The first attempt to place the essure device on the patient's left side resulted in difficulty in inserting the device.Essure device on the left side resulted in the coil being released, but then it would not separate from the insertion device.Therefore the coil was retracted along with the insertion device.Discrepancy noted as per pfs dated (b)(6) 2019, date of insertion noted (b)(6) 2010, previously it was reported (b)(6) 2008.Leave taken from this job or other job for medical reasons -maternity bedrest and child birth, cancer and radical hysterectomy.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2005: several filling defects present within the endometrial cavity, adequate cornual filling.Right tubal occlusion with right tubal microinsert.Faint opacification of terminal portion of the left uterine tube with no intraperitoneal spillage of contrast.Pregnancy test urine - on (b)(6) 2005: negative.Ultrasound scan vagina - on an unknown date: results: total bilateral occlusion.Concerning the injuries reported in this case, the following one was reported via medical records: device dislocation.Lot number reported 12277837 is invalid.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 28-may-2019: quality-safety evaluation of ptc (product technical complaint).Incident no valid lot number or device sample was received in this case.We will conduct a review of our complaint records and other non-conformances 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 ('coils right unable / failed on left side'), pelvic pain ('pain/pelvic area'), uterine cancer ('tumor / teratoma / cancer type: uterine') and cervix carcinoma ('tumor / teratoma / cancer type: cervical') in a 37-year-old female patient who had essure (ess205) (batch no.12277837) 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 vaginal delivery (vaginal delivery: (b)(6) 2005.) on (b)(6) 2005, depression from 2003 to 2018, miscarriage in 1987, multigravida, parity 4 (on ((b)(6) 1991, (b)(6) 1994, (b)(6) 2005, (b)(6) 2007).), c-section (emergency c-section with last pregnancy after essure.), necrosis nos, dizzy, chills, menorrhagia, dysfunctional uterine bleeding, cervical dysplasia, uterus enlarged and peritoneal adhesions.Previously administered products included for an unreported indication: effexor.Concurrent conditions included nausea, vomiting, hives, diabetes, depression, anemia, tobacco abuse, deep vein thrombosis, dysfunctional uterine bleeding, cervical dysplasia and sleep apnea.Concomitant products included medroxyprogesterone acetate (depo provera), naproxen and sertraline hydrochloride (zoloft) from 2003 to 2018.On (b)(6) 2005, the patient had essure (ess205) inserted.In (b)(6) 2005, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)").In (b)(6) 2006, the patient experienced flank pain ("flank pain").In 2006, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).In (b)(6) 2006, the patient was found to have a pregnancy with contraceptive device ("pregnancy (with complications)").In (b)(6) 2008, the patient was found to have uterine cancer (seriousness criterion medically significant) and cervix carcinoma (seriousness criterion medically significant).In (b)(6) 2008, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)/unusual bleeding"), heavy menstrual bleeding ("abnormal bleeding (vaginal, menorrhagia);"), dysmenorrhoea ("dysmenorrhea cramping);") and vaginal discharge ("vaginal discharge.").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) and urinary tract disorder ("urinary problems").The patient was treated with surgery (hysterectomy with bilateral salpingo-oopherectomy and hysterectomy with bilateral salpingo-oopherectomy, dilatation and curettage).Essure (ess205) was removed on (b)(6) 2010.At the time of the report, the device dislocation, pregnancy with contraceptive device, dysmenorrhoea, dyspareunia, flank pain and urinary tract disorder outcome was unknown and the pelvic pain, uterine cancer, cervix carcinoma, vaginal haemorrhage, heavy menstrual bleeding and vaginal discharge had resolved.Pregnancy related information: prospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure (ess205) occurred during the first trimester.The pregnancy outcome was not reported.The reporter considered cervix carcinoma, device dislocation, dysmenorrhoea, dyspareunia, flank pain, heavy menstrual bleeding, pelvic pain, pregnancy with contraceptive device, urinary tract disorder, uterine cancer, vaginal discharge and vaginal haemorrhage to be related to essure (ess205).The reporter commented: coils right unable, left coils showing.The first attempt to place the essure device on the patient's left side resulted in difficulty in inserting the device.Essure device on the left side resulted in the coil being released, but then it would not separate from the insertion device.Therefore the coil was retracted along with the insertion device.Discrepancy noted as per pfs dated (b)(6) 2020, date of insertion noted (b)(6) 2010, previously it was reported (b)(6) 2008.Discrepancy noted in date of removal (b)(6) 2010.Leave taken from this job or other job for medical reasons -maternity bedrest and child birth, cancer and radical hysterectomy diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram on (b)(6) 2005: several filling defects present within the endometrial cavity, adequate cornual filling.Right tubal occlusion with right tubal microinsert.Faint opacification of terminal portion of the left uterine tube with no intraperitoneal spillage of contrast.Pregnancy test urine on (b)(6) 2005: negative.Ultrasound scan vagina on an unknown date: results: total bilateral occlusion.Concerning the injuries reported in this case, the following one was reported via medical records: device dislocation.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 (b)(6) 2021: quality safety evaluation of ptc.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 ('coils right unable / failed on left side'), pelvic pain ('pain/pelvic area'), uterine cancer ('tumor / teratoma / cancer type: uterine') and cervix carcinoma ('tumor / teratoma / cancer type: cervical') in a 37-year-old female patient who had essure (ess205) (batch no.12277837) 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 vaginal delivery (vaginal delivery: (b)(6) 2005.) on (b)(6) 2005, depression from 2003 to 2018, miscarriage in 1987, multigravida, parity 4 (on ((b)(6) 1991, (b)(6) 1994, (b)(6) 2005, (b)(6) 2007).), c-section (emergency c-section with last pregnancy after essure.), necrosis nos, dizzy, chills, menorrhagia, dysfunctional uterine bleeding, cervical dysplasia, uterus enlarged and peritoneal adhesions.Previously administered products included for an unreported indication: effexor.Concurrent conditions included nausea, vomiting, hives, diabetes, depression, anemia, tobacco abuse, deep vein thrombosis, dysfunctional uterine bleeding, cervical dysplasia and sleep apnea.Concomitant products included medroxyprogesterone acetate (depo provera), naproxen and sertraline hydrochloride (zoloft) from 2003 to 2018.On (b)(6) 2005, the patient had essure (ess205) inserted.In (b)(6) 2005, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)").In (b)(6) 2006, the patient experienced flank pain ("flank pain").In 2006, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).In (b)(6) 2006, the patient was found to have a pregnancy with contraceptive device ("pregnancy (with complications)").In (b)(6) 2008, the patient was found to have uterine cancer (seriousness criterion medically significant) and cervix carcinoma (seriousness criterion medically significant).In (b)(6) 2008, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)/unusual bleeding"), heavy menstrual bleeding ("abnormal bleeding (vaginal, menorrhagia);"), dysmenorrhoea ("dysmenorrhea cramping);") and vaginal discharge ("vaginal discharge.").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) and urinary tract disorder ("urinary problems").The patient was treated with surgery (hysterectomy with bilateral salpingo-oopherectomy and hysterectomy with bilateral salpingo-oopherectomy, dilatation and curettage).Essure (ess205) was removed on (b)(6) 2010.At the time of the report, the device dislocation, pregnancy with contraceptive device, dysmenorrhoea, dyspareunia, flank pain and urinary tract disorder outcome was unknown and the pelvic pain, uterine cancer, cervix carcinoma, vaginal haemorrhage, heavy menstrual bleeding and vaginal discharge had resolved.Pregnancy related information: prospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure (ess205) occurred during the first trimester.The pregnancy outcome was not reported.The reporter considered cervix carcinoma, device dislocation, dysmenorrhoea, dyspareunia, flank pain, heavy menstrual bleeding, pelvic pain, pregnancy with contraceptive device, urinary tract disorder, uterine cancer, vaginal discharge and vaginal haemorrhage to be related to essure (ess205).The reporter commented: coils right unable, left coils showing.The first attempt to place the essure device on the patient's left side resulted in difficulty in inserting the device.Essure device on the left side resulted in the coil being released, but then it would not separate from the insertion device.Therefore the coil was retracted along with the insertion device.Discrepancy noted as per pfs dated (b)(6) 2019, date of insertion noted (b)(6) 2010, previously it was reported (b)(6) 2008.Discrepancy noted in date of removal (b)(6) 2010.Leave taken from this job or other job for medical reasons -maternity bedrest and child birth, cancer and radical hysterectomy diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2005: several filling defects present within the endometrial cavity, adequate cornual filling.Right tubal occlusion with right tubal microinsert.Faint opacification of terminal portion of the left uterine tube with no intraperitoneal spillage of contrast.Pregnancy test urine - on (b)(6) 2005: negative.Ultrasound scan vagina - on an unknown date: results: total bilateral occlusion.Concerning the injuries reported in this case, the following one was reported via medical records: device dislocation.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 16-jun-2021: quality safety evaluation of ptc.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 ('coils right unable / failed on left side'), pelvic pain ('pain/pelvic area'), uterine cancer ('tumor / teratoma / cancer type: uterine') and cervix carcinoma ('tumor / teratoma / cancer type: cervical') in a 37-year-old female patient who had essure (ess205) (batch no.12277837-inv) 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 vaginal delivery (vaginal delivery: (b)(6) 2005.) on (b)(6) 2005, depression from 2003 to 2018, miscarriage in 1987, multigravida, parity 4 (on ((b)(6) 1991, (b)(6) 1994, (b)(6) 2005, (b)(6) 2007).), c-section (emergency c-section with last pregnancy after essure.), necrosis nos, dizzy, chills, menorrhagia, dysfunctional uterine bleeding, cervical dysplasia, uterus enlarged and peritoneal adhesions.Previously administered products included for an unreported indication: effexor.Concurrent conditions included nausea, vomiting, hives, diabetes, depression, anemia, tobacco abuse, deep vein thrombosis, dysfunctional uterine bleeding, cervical dysplasia and sleep apnea.Concomitant products included medroxyprogesterone acetate (depo provera), naproxen and sertraline hydrochloride (zoloft) from 2003 to 2018.On (b)(6) 2005, the patient had essure (ess205) inserted.In (b)(6) 2005, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)").In (b)(6) 2006, the patient experienced flank pain ("flank pain").In 2006, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).In (b)(6) 2006, the patient was found to have a pregnancy with contraceptive device ("pregnancy (with complications)").In (b)(6) 2008, the patient was found to have uterine cancer (seriousness criterion medically significant) and cervix carcinoma (seriousness criterion medically significant).In (b)(6) 2008, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)/unusual bleeding"), heavy menstrual bleeding ("abnormal bleeding (vaginal, menorrhagia);"), dysmenorrhoea ("dysmenorrhea cramping);") and vaginal discharge ("vaginal discharge.").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) and urinary tract disorder ("urinary problems").The patient was treated with surgery (hysterectomy with bilateral salpingo-oopherectomy and hysterectomy with bilateral salpingo-oopherectomy, dilatation and curettage).Essure (ess205) was removed on (b)(6) 2010.At the time of the report, the device dislocation, pregnancy with contraceptive device, dysmenorrhoea, dyspareunia, flank pain and urinary tract disorder outcome was unknown and the pelvic pain, uterine cancer, cervix carcinoma, vaginal haemorrhage, heavy menstrual bleeding and vaginal discharge had resolved.Pregnancy related information: prospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure (ess205) occurred during the first trimester.The pregnancy outcome was not reported.The reporter considered cervix carcinoma, device dislocation, dysmenorrhoea, dyspareunia, flank pain, heavy menstrual bleeding, pelvic pain, pregnancy with contraceptive device, urinary tract disorder, uterine cancer, vaginal discharge and vaginal haemorrhage to be related to essure (ess205).The reporter commented: coils right unable, left coils showing.The first attempt to place the essure device on the patient's left side resulted in difficulty in inserting the device.Essure device on the left side resulted in the coil being released, but then it would not separate from the insertion device.Therefore the coil was retracted along with the insertion device.Discrepancy noted as per pfs dated (b)(6) 2019, date of insertion noted (b)(6) 2010, previously it was reported (b)(6) 2008.Discrepancy noted in date of removal (b)(6) 2010.Leave taken from this job or other job for medical reasons -maternity bedrest and child birth, cancer and radical hysterectomy.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2005: several filling defects present within the endometrial cavity, adequate cornual filling.Right tubal occlusion with right tubal microinsert.Faint opacification of terminal portion of the left uterine tube with no intraperitoneal spillage of contrast.Pregnancy test urine - on (b)(6) 2005: negative.Ultrasound scan vagina - on an unknown date: results: total bilateral occlusion.Concerning the injuries reported in this case, the following one was reported via medical records: device dislocation.Lot number reported 12277837 is not valid.Quality-safety evaluation of ptc: unable to confirm complaint.Amendment: the report was amended for the following reason: ccc correction done.No new follow-up information was received from the reporter.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation 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 ('coils right unable / failed on left side'), pelvic pain ('pain/pelvic area'), uterine cancer ('tumor / teratoma / cancer type: uterine') and cervix carcinoma ('tumor / teratoma / cancer type: cervical') in a 37-year-old female patient who had essure (ess205) (batch no: 12277837-inv) 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 vaginal delivery (vaginal delivery: on (b)(6) 2005.) on (b)(6) 2005, depression from 2003 to 2018, miscarriage in 1987, multigravida, parity 4 (on (b)(6)1991, on (b)(6) 1994, on (b)(6) 2005, on (b)(6) 2007).), c-section (emergency c-section with last pregnancy after essure.), necrosis nos, dizzy, chills, menorrhagia, dysfunctional uterine bleeding, cervical dysplasia, uterus enlarged and peritoneal adhesions.Previously administered products included for an unreported indication: effexor.Concurrent conditions included nausea, vomiting, hives, diabetes, depression, anemia, tobacco abuse, deep vein thrombosis, dysfunctional uterine bleeding, cervical dysplasia and sleep apnea.Concomitant products included medroxyprogesterone acetate (depo provera), naproxen and sertraline hydrochloride (zoloft) from 2003 to 2018.On (b)(6) 2005, the patient had essure (ess205) inserted.On (b)(6) 2005, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)").On (b)(6) 2006, the patient experienced flank pain ("flank pain").In 2006, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On (b)(6) 2006, the patient was found to have a pregnancy with contraceptive device ("pregnancy (with complications)").On (b)(6) 2008, the patient was found to have uterine cancer (seriousness criterion medically significant) and cervix carcinoma (seriousness criterion medically significant).On (b)(6) 2008, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia) / unusual bleeding"), heavy menstrual bleeding ("abnormal bleeding (vaginal, menorrhagia);"), dysmenorrhoea ("dysmenorrhea cramping);") and vaginal discharge ("vaginal discharge.").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) and urinary tract disorder ("urinary problems").The patient was treated with surgery (hysterectomy with bilateral salpingo-oopherectomy and hysterectomy with bilateral salpingo-oopherectomy, dilatation and curettage).Essure (ess205) was removed on (b)(6) 2010.At the time of the report, the device dislocation, pregnancy with contraceptive device, dysmenorrhoea, dyspareunia, flank pain and urinary tract disorder outcome was unknown and the pelvic pain, uterine cancer, cervix carcinoma, vaginal haemorrhage, heavy menstrual bleeding and vaginal discharge had resolved.Pregnancy related information: prospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure (ess205) occurred during the first trimester.The pregnancy outcome was not reported.The reporter considered cervix carcinoma, device dislocation, dysmenorrhoea, dyspareunia, flank pain, heavy menstrual bleeding, pelvic pain, pregnancy with contraceptive device, urinary tract disorder, uterine cancer, vaginal discharge and vaginal haemorrhage to be related to essure (ess205).The reporter commented: coils right unable, left coils showing.The first attempt to place the essure device on the patient's left side resulted in difficulty in inserting the device.Essure device on the left side resulted in the coil being released, but then it would not separate from the insertion device.Therefore the coil was retracted along with the insertion device.Discrepancy noted as per pfs dated on (b)(6) 2019, date of insertion noted on (b)(6) 2010, previously it was reported on (b)(6) 2008.Discrepancy noted in date of removal on (b)(6) 2010.Leave taken from this job or other job for medical reasons -maternity bedrest and child birth, cancer and radical hysterectomy.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram: on (b)(6) 2005: several filling defects present within the endometrial cavity, adequate cornual filling.Right tubal occlusion with right tubal microinsert.Faint opacification of terminal portion of the left uterine tube with no intraperitoneal spillage of contrast.Pregnancy test urine: on (b)(6) 2005: negative.Ultrasound scan vagina: on an unknown date: results: total bilateral occlusion.Concerning the injuries reported in this case, the following one was reported via medical records: device dislocation.Lot number reported 12277837 is not valid.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 28-may-2021: mr received.Patient middle name 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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