| Model Number ESS305 |
| Device Problems
Break (1069); Device Inoperable (1663); Patient-Device Incompatibility (2682); Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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| Patient Problems
Ectopic Pregnancy (1819); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Menstrual Irregularities (1959); Perforation (2001); Uterine Perforation (2121); Device Embedded In Tissue or Plaque (3165); Fallopian Tube Perforation (4506); Genital Bleeding (4507); Pregnancy with a Contraceptive Device (4517); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 12/01/2010 |
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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 breakage ("fracture of device"), fallopian tube perforation ("perforation by the device") and ectopic pregnancy with contraceptive device ("ectopic pregnancy") in a female patient who had essure 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".On (b)(6) 2008, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain, ectopic pregnancy with contraceptive device (seriousness criteria medically significant and intervention required), hypersensitivity ("allergic reaction"), menstrual disorder ("menstrual issues") and infection ("infections").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 (underwent a failed hysterectomy).At the time of the report, the device breakage, fallopian tube perforation, ectopic pregnancy with contraceptive device, hypersensitivity, menstrual disorder and infection outcome was unknown.The reporter considered device breakage, ectopic pregnancy with contraceptive device, fallopian tube perforation, hypersensitivity, infection and menstrual disorder to be related to essure.Incident: no lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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Prospective pregnancy case was reported by a lawyer and describes the occurrence of device breakage ("fracture of device"), fallopian tube perforation ("perforation by the device"), ectopic pregnancy with contraceptive device ("ectopic pregnancy") and genital haemorrhage ("abnormal bleeding") in an adult female patient who had essure (batch no.626277) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".The patient's previously administered products included for an unreported indication: depo shot from 2002 to 2005.On (b)(6) 2008, the patient had essure inserted.In (b)(6) 2008, the patient experienced depression ("depression"), anxiety ("mental anguish"), dysmenorrhoea ("dysmenorrhea (cramping)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)") and menometrorrhagia ("menometrorrhagia").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain, ectopic pregnancy with contraceptive device (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), hypersensitivity ("allergic reaction"), menstrual disorder ("menstrual issues") and infection ("infections").Last menstrual period and estimated date of delivery were not provided.The patient was treated with surgery (underwent a failed hysterectomy / surgical removal of coil(s)) and surgery (surgical removal of coil(s)).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, fallopian tube perforation, ectopic pregnancy with contraceptive device, hypersensitivity, menstrual disorder, infection, depression, anxiety, vaginal haemorrhage, menorrhagia and menometrorrhagia outcome was unknown, the genital haemorrhage was resolving and the dysmenorrhoea had resolved.The reporter considered anxiety, depression, device breakage, dysmenorrhoea, ectopic pregnancy with contraceptive device, fallopian tube perforation, genital haemorrhage, hypersensitivity, infection, menometrorrhagia, menorrhagia, menstrual disorder and vaginal haemorrhage to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 20-sep-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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Rospective pregnancy case was reported by a lawyer and describes the occurrence of device breakage ("fracture of device"), fallopian tube perforation ("perforation by the device"), ectopic pregnancy with contraceptive device ("ectopic pregnancy") and genital haemorrhage ("abnormal bleeding") in an adult female patient who had essure (batch no.626277) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".The patient's previously administered products included for an unreported indication: depo shot from 2002 to 2005.On (b)(6) 2008, the patient had essure inserted.In (b)(6) 2008, the patient experienced depression ("depression"), anxiety ("mental anguish"), dysmenorrhoea ("dysmenorrhea (cramping)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)") and menometrorrhagia ("menometrorrhagia").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain, ectopic pregnancy with contraceptive device (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), hypersensitivity ("allergic reaction"), menstrual disorder ("menstrual issues") and infection ("infections").Last menstrual period and estimated date of delivery were not provided.The patient was treated with surgery (underwent a failed hysterectomy / surgical removal of coil(s)) and surgery (surgical removal of coil(s)).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, fallopian tube perforation, ectopic pregnancy with contraceptive device, hypersensitivity, menstrual disorder, infection, depression, anxiety, vaginal haemorrhage, menorrhagia and menometrorrhagia outcome was unknown, the genital haemorrhage was resolving and the dysmenorrhoea had resolved.The reporter considered anxiety, depression, device breakage, dysmenorrhoea, ectopic pregnancy with contraceptive device, fallopian tube perforation, genital haemorrhage, hypersensitivity, infection, menometrorrhagia, menorrhagia, menstrual disorder and vaginal haemorrhage to be related to essure.Most recent follow-up information incorporated above includes: on 7-sep-2018: pfs received - new event "abnormal bleeding, depression, mental anguish, dysmenorrhea (cramping),, abnormal bleeding (vaginal), abnormal bleeding (menorrhagia), menometrorrhagia" were added.Lot number was added.Product explant date was added.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 breakage ("fracture of device"), fallopian tube perforation ("perforation by the device"), pregnancy with contraceptive device ("pregnant with essure micro-insert"), abortion spontaneous ("pregnancy (stillbirth or miscarriage),") and genital haemorrhage ("abnormal bleeding") in a 26-year-old female patient who had essure (batch no.626277) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective" on (b)(6) 2009 and device monitoring procedure not performed "did not underwent for essure confirmation test".The patient's medical history included gravida ii and parity 5.Previously administered products included for an unreported indication: depo shot from 2002 to 2005.Concomitant products included ibuprofen and paracetamol (acetaminophen).On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2009, the patient experienced depression ("depression"), anxiety ("mental anguish"), dysmenorrhoea ("dysmenorrhea (cramping)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)") and menometrorrhagia ("menometrorrhagia"), 3 months 9 days after insertion of essure.On (b)(6) 2009, the patient experienced abortion spontaneous (seriousness criterion medically significant), hot flush ("hot flashes") and mood swings ("mood swing").On (b)(6) 2009, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)").On (b)(6) 2010, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant).On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain, genital haemorrhage (seriousness criterion medically significant), hypersensitivity ("allergic reaction"), menstrual disorder ("menstrual issues"), infection ("infections"), back pain ("lower back pain") and abdominal pain ("abdominal pain").The patient was treated with surgery (underwent a failed hysterectomy / surgical removal of coil(s)).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, fallopian tube perforation, pregnancy with contraceptive device, abortion spontaneous, hypersensitivity, menstrual disorder, infection, depression, anxiety, menometrorrhagia, hot flush, mood swings and dyspareunia outcome was unknown, the genital haemorrhage, vaginal haemorrhage, menorrhagia, back pain and abdominal pain was resolving and the 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 spontaneous abortion.The reporter considered abdominal pain, abortion spontaneous, anxiety, back pain, depression, device breakage, dysmenorrhoea, dyspareunia, fallopian tube perforation, genital haemorrhage, hot flush, hypersensitivity, infection, menometrorrhagia, menorrhagia, menstrual disorder, mood swings, pregnancy with contraceptive device and vaginal haemorrhage to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 30-nov-2018: pfs received-new event dyspareunia (painful sexual intercourse), hot flashes, mood swing, pregnant with essure micro-insert, low back pain, abdominal pain, did not underwent for essure confirmation test were added.Outcome of vaginal haemorrhage, menorrhagia updated to recovering / resolving.Pt of ectopic pregnancy with contraceptive device updated to abortion spontaneous.Pregnancy outcome updated.Concomitant drug and medical history were 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 spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('fracture of device'), fallopian tube perforation ('perforation by the device'), pregnancy with contraceptive device ('pregnant with essure micro-insert'), abortion spontaneous ('pregnancy (stillbirth or miscarriage),') and genital haemorrhage ('abnormal bleeding') in a 26-year-old female patient who had essure (batch no.626277) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective" on (b)(6) 2009 and device monitoring procedure not performed "did not underwent for essure confirmation test".The patient's medical history included multigravida and parity 5.Previously administered products included for an unreported indication: depo shot from 2002 to 2005 and loestrin.Concomitant products included ibuprofen and paracetamol (acetaminophen).On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2009, the patient experienced depression ("depression"), anxiety ("mental anguish"), dysmenorrhoea ("dysmenorrhea (cramping)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)") and menometrorrhagia ("menometrorrhagia"), 3 months 9 days after insertion of essure.On (b)(6) 2009, the patient experienced abortion spontaneous (seriousness criterion medically significant), hot flush ("hot flashes") and mood swings ("mood swing").On (b)(6) 2009, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)").On (b)(6) 2010, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant).On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain, genital haemorrhage (seriousness criterion medically significant), hypersensitivity ("allergic reaction"), menstrual disorder ("menstrual issues"), infection ("infections"), back pain ("lower back pain"), abdominal pain ("abdominal pain"), bladder disorder ("bladder problems"), urinary tract disorder ("urinary tract problems"), urinary tract infection ("uti"), cystitis ("bladder infection"), vaginal infection ("vaginal infection") and vaginal discharge ("vaginal discharge").The patient was treated with surgery (underwent a failed hysterectomy / surgical removal of coil(s)).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, fallopian tube perforation, pregnancy with contraceptive device, abortion spontaneous, menstrual disorder, infection, depression, anxiety, menometrorrhagia, hot flush, mood swings and dyspareunia outcome was unknown, the genital haemorrhage, hypersensitivity, dysmenorrhoea, vaginal haemorrhage, menorrhagia, bladder disorder, urinary tract disorder, urinary tract infection, cystitis, vaginal infection and vaginal discharge had resolved and the back pain and abdominal pain was resolving.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 spontaneous abortion.The reporter considered abdominal pain, abortion spontaneous, anxiety, back pain, bladder disorder, cystitis, depression, device breakage, dysmenorrhoea, dyspareunia, fallopian tube perforation, genital haemorrhage, hot flush, hypersensitivity, infection, menometrorrhagia, menorrhagia, menstrual disorder, mood swings, pregnancy with contraceptive device, urinary tract disorder, urinary tract infection, vaginal discharge, vaginal haemorrhage and vaginal infection to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 9-jan-2020: pif received: events added: bladder problems, urinary tract problems, uti, vaginal infection, bladder infection, vaginal discharge.Event outcome were 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 device breakage ('fracture of device'), fallopian tube perforation ('perforation by the device'), pregnancy with contraceptive device ('pregnant with essure micro-insert'), abortion spontaneous ('pregnancy (stillbirth or miscarriage),') and genital haemorrhage ('abnormal bleeding') in a 26-year-old female patient who had essure (batch no.626277) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective" on (b)(6) 2009 and device monitoring procedure not performed "did not underwent for essure confirmation test".The patient's medical history included multigravida and parity 5.Previously administered products included for an unreported indication: depo shot from 2002 to 2005 and loestrin.Concurrent conditions included ovarian cyst.Concomitant products included ibuprofen and paracetamol (acetaminophen).On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2009, the patient experienced depression ("depression"), anxiety ("mental anguish"), dysmenorrhoea ("dysmenorrhea (cramping)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)") and menometrorrhagia ("menometrorrhagia"), 3 months 9 days after insertion of essure.On (b)(6) 2009, the patient experienced abortion spontaneous (seriousness criterion medically significant), hot flush ("hot flashes") and mood swings ("mood swing").On (b)(6) 2009, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)").On (b)(6) 2010, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant).On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain, genital haemorrhage (seriousness criterion medically significant), hypersensitivity ("allergic reaction"), menstrual disorder ("menstrual issues"), infection ("infections"), back pain ("lower back pain"), abdominal pain ("abdominal pain"), bladder disorder ("bladder problems"), urinary tract disorder ("urinary tract problems"), urinary tract infection ("uti"), cystitis ("bladder infection"), vaginal infection ("vaginal infection") and vaginal discharge ("vaginal discharge").The patient was treated with surgery (surgical removal of coil(s)hysteroscopically removed).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, fallopian tube perforation, pregnancy with contraceptive device, abortion spontaneous, menstrual disorder, infection, depression, anxiety, menometrorrhagia, hot flush, mood swings and dyspareunia outcome was unknown, the genital haemorrhage, hypersensitivity, dysmenorrhoea, vaginal haemorrhage, menorrhagia, bladder disorder, urinary tract disorder, urinary tract infection, cystitis, vaginal infection and vaginal discharge had resolved and the back pain and abdominal pain was resolving.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 spontaneous abortion.The reporter considered abdominal pain, abortion spontaneous, anxiety, back pain, bladder disorder, cystitis, depression, device breakage, dysmenorrhoea, dyspareunia, fallopian tube perforation, genital haemorrhage, hot flush, hypersensitivity, infection, menometrorrhagia, menorrhagia, menstrual disorder, mood swings, pregnancy with contraceptive device, urinary tract disorder, urinary tract infection, vaginal discharge, vaginal haemorrhage and vaginal infection to be related to essure.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: pelvic pain, menometrorrhagia, dysmenorrhea quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 24-mar-2021: mr received.Reporter information, medical history and auto narrative supplement were added.Real fu was received and there was no significant change in the medical context of case.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 breakage ('fracture of device'), fallopian tube perforation ('perforation by the device'), pregnancy with contraceptive device ('pregnant with essure micro-insert'), abortion spontaneous ('pregnancy (stillbirth or miscarriage),') and genital haemorrhage ('abnormal bleeding') in a 26-year-old female patient who had essure (batch no.626277) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective" on (b)(6) 2009 and device monitoring procedure not performed "did not underwent for essure confirmation test".The patient's medical history included multigravida and parity 5.Previously administered products included for an unreported indication: depo shot from 2002 to 2005 and loestrin.Concurrent conditions included ovarian cyst.Concomitant products included ibuprofen and paracetamol (acetaminophen).On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2009, the patient experienced depression ("depression"), anxiety ("mental anguish"), dysmenorrhoea ("dysmenorrhea (cramping)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)") and menometrorrhagia ("menometrorrhagia"), 3 months 9 days after insertion of essure.On (b)(6) 2009, the patient experienced abortion spontaneous (seriousness criterion medically significant), hot flush ("hot flashes") and mood swings ("mood swing").On (b)(6) 2009, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)").On (b)(6) 2010, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant).On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain, genital haemorrhage (seriousness criterion medically significant), hypersensitivity ("allergic reaction"), menstrual disorder ("menstrual issues"), infection ("infections"), back pain ("lower back pain"), abdominal pain ("abdominal pain"), bladder disorder ("bladder problems"), urinary tract disorder ("urinary tract problems"), urinary tract infection ("uti"), cystitis ("bladder infection"), vaginal infection ("vaginal infection") and vaginal discharge ("vaginal discharge").The patient was treated with surgery (surgical removal of coil(s)hysteroscopically removed).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, fallopian tube perforation, pregnancy with contraceptive device, abortion spontaneous, menstrual disorder, infection, depression, anxiety, menometrorrhagia, hot flush, mood swings and dyspareunia outcome was unknown, the genital haemorrhage, hypersensitivity, dysmenorrhoea, vaginal haemorrhage, menorrhagia, bladder disorder, urinary tract disorder, urinary tract infection, cystitis, vaginal infection and vaginal discharge had resolved and the back pain and abdominal pain was resolving.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 spontaneous abortion.The reporter considered abdominal pain, abortion spontaneous, anxiety, back pain, bladder disorder, cystitis, depression, device breakage, dysmenorrhoea, dyspareunia, fallopian tube perforation, genital haemorrhage, hot flush, hypersensitivity, infection, menometrorrhagia, menorrhagia, menstrual disorder, mood swings, pregnancy with contraceptive device, urinary tract disorder, urinary tract infection, vaginal discharge, vaginal haemorrhage and vaginal infection to be related to essure.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: pelvic pain, menometrorrhagia, dysmenorrhea lot number: 626277 manufacturing date: 2007/11 expiration date: 2009/10.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 1-apr-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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