| Model Number ESS305 |
| Device Problems
Positioning Failure (1158); Patient-Device Incompatibility (2682); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Patient Device Interaction Problem (4001); Migration (4003)
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| Patient Problems
Abdominal Pain (1685); Emotional Changes (1831); Hemorrhage/Bleeding (1888); Failure of Implant (1924); Unspecified Infection (1930); Uterine Perforation (2121); Cramp(s) (2193); Device Embedded In Tissue or Plaque (3165); No Code Available (3191); Pregnancy (3193); Fallopian Tube Perforation (4506)
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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 uterine perforation ('uterus perforation / migration'), pregnancy with contraceptive device ('pregnancy (no complication)') and genital haemorrhage ('general abnormal bleeding') in an adult 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) 2012, the patient had essure inserted.On an unknown date, the patient experienced uterine perforation (seriousness criterion medically significant), genital haemorrhage (seriousness criterion medically significant), pelvic pain ("pelvic pain"), abdominal pain ("abdominal pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), psychological trauma ("psych injury") and vaginal infection ("vaginal infection") and was found to have a pregnancy with contraceptive device (seriousness criterion medically significant).Essure treatment was not changed.At the time of the report, the uterine perforation, pregnancy with contraceptive device, genital haemorrhage, pelvic pain, abdominal pain, dysmenorrhoea, dyspareunia, psychological trauma and vaginal infection outcome was unknown.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, second and third trimesters.The pregnancy outcome was reported as a live birth.It was unknown whether the child was healthy.The reporter considered abdominal pain, dysmenorrhoea, dyspareunia, genital haemorrhage, pelvic pain, pregnancy with contraceptive device, psychological trauma, uterine perforation and vaginal infection to be related to essure.The reporter commented: patient received treatment for pelvic pain, abdominal pain, dysmenorrhea (cramping) ,dyspareunia (painful sexual intercourse), general abnormal bleeding, psych injury, migration, perforation and vaginal infection.Diagnostic results (normal ranges are provided in parenthesis if available): imaging procedure: on (b)(6) 2012: essure confirmation test(s) (unspecified) bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 5-sep-2019: pfs received.Previously reported event "injury" was updated to "pelvic pain", events- " migration, uterus perforation, pregnancy, general abnormal bleeding, device ineffective, abdominal pain, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), psych injury and vaginal infection", lab data was added incident: 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 uterine perforation ('uterus perforation /migration of essure device -the metallic foreign body embedded in the region of the left cornu extending outside the uterus') and embedded device ('partially embedded in the (l) fallopian tube') in an adult female patient who had essure (batch no.898925) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: medical device monitoring error "no visible ostium to the right fallopian tube, and therefore, the essure procedure was only performed on the left" and device ineffective "device ineffective".The patient's medical history included anemia, arthritis, parity 4 and miscarriage (3 miscarriages).Concomitant products included alprazolam, amitriptyline, bupropion hydrochloride (act bupropion xl), butalbital;caffeine;paracetamol (fioricet), clonazepam, ethinylestradiol;norethisterone acetate (loestrin), hydrocodone, nsaids, paracetamol (acetaminophen), rizatriptan and sumatriptan (imitrex).On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced pelvic pain ("pelvic pain"), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal infection ("vaginal infection"), menorrhagia ("abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), depression ("psychological or psychiatric problems - depression"), anxiety ("anxiety/mental anguish"), migraine ("migraines / headaches"), menstrual cramp ("dysmenorrhea (cramping)"), vaginal discharge ("vaginal discharge") and fatigue ("fatigue").On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), genital haemorrhage ("general abnormal bleeding"), abdominal pain ("abdominal pain"), menstrual cramps ("dysmennorhea (cramping)"), psychological trauma ("psych injury"), back pain ("lower back area pain"), headache ("headaches") and complication of device insertion ("complications or problems that occurred at the time of essure placement procedure-unable to visualized right ostia, so, inability to place essure") and was found to have a pregnancy with contraceptive device ("pregnancy (no complication)").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2019.At the time of the report, the uterine perforation, embedded device, pregnancy with contraceptive device, genital haemorrhage, abdominal pain, menstrual cramps, dyspareunia, psychological trauma, vaginal infection, menorrhagia, vaginal haemorrhage, depression, anxiety, migraine, menstrual cramp, fatigue and complication of device insertion outcome was unknown and the pelvic pain, back pain and headache was resolving.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 8, para 5.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first, second and third trimesters.The pregnancy outcome was reported as a live birth.It was unknown whether the child was healthy.The reporter considered abdominal pain, anxiety, back pain, complication of device insertion, depression, dyspareunia, embedded device, fatigue, genital haemorrhage, headache, menorrhagia, menstrual cramp, migraine, pelvic pain, pregnancy with contraceptive device, psychological trauma, uterine perforation, vaginal discharge, vaginal haemorrhage, vaginal infection and menstrual cramps to be related to essure.The reporter commented: patient received treatment for pelvic pain, abdominal pain, dysmennorhea (cramping) ,dyspareunia (painful sexual intercourse), general abnormal bleeding, psych injury, migration, perforation and vaginal infection.The tralling coils in the left ostia was 3.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2012: post essure procedure on the left with no spillage from the left tube.Apparent occluded right ostium to the right fallopian tube.Right fallopian tube not opacified.No spillage on the right; on (b)(6) 2012: unilateral occlusion (left tube occluded).Imaging procedure - on (b)(6) 2012: essure confirmation test(s) (unspecified) bilateral occlusion.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: dysmenorrhea, dyspareunia, pelvic pain, vaginal discharge, vaginal haemorrhage, anxiety, migraine, embedded device, back pain.Lot number: 898925 manufacturing date: 2011-08 expiration date: 2014-08.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 5-mar-2020: 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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ('uterus perforation /migration of essure device -the metallic foreign body embedded in the region of the left cornu extending outside the uterus'), fallopian tube perforation ('perforation: fallopian tube') and embedded device ('partially embedded in the (l) fallopian tube') in a 35-year-old female patient who had essure (batch no.898925) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: medical device monitoring error "no visible ostium to the right fallopian tube, and therefore, the essure procedure was only performed on the left" and device ineffective "device ineffective".The patient's medical history included anemia, arthritis, parity 4 and miscarriage (3 miscarriages).Concomitant products included alprazolam, amitriptyline, bupropion hydrochloride (act bupropion xl), butalbital;caffeine;paracetamol (fioricet), clonazepam, ethinylestradiol;norethisterone acetate (loestrin), hydrocodone, nsaids, paracetamol (acetaminophen), rizatriptan and sumatriptan (imitrex).On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced pelvic pain ("pelvic pain"), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal infection ("vaginal infection"), menorrhagia ("abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), depression ("psychological or psychiatric problems - depression"), anxiety ("anxiety/mental anguish"), migraine ("migraines / headaches"), menstrual cramp ("dysmenorrhea (cramping)"), vaginal discharge ("vaginal discharge") and fatigue ("fatigue").On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criterion medically significant), embedded device (seriousness criteria medically significant and intervention required), genital haemorrhage ("general abnormal bleeding"), abdominal pain ("abdominal pain"), menstrual cramps ("dysmenorrhea (cramping)"), psychological trauma ("psych injury"), back pain ("lower back area pain"), headache ("headaches"), complication of device insertion ("complications or problems that occurred at the time of essure placement procedure-unable to visualized right ostia, so, inability to place essure"), urinary tract infection ("urinary problems: uti") and cystitis ("bladder problem- bladder infection") and was found to have a pregnancy with contraceptive device ("pregnancy (no complication)").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2019.At the time of the report, the uterine perforation, fallopian tube perforation, embedded device, pregnancy with contraceptive device, psychological trauma, menorrhagia, vaginal haemorrhage, depression, anxiety, migraine, menstrual cramp, fatigue and complication of device insertion outcome was unknown, the genital haemorrhage, pelvic pain, abdominal pain, menstrual cramps, dyspareunia, vaginal infection, vaginal discharge, urinary tract infection and cystitis had resolved and the back pain and headache was resolving.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 8, para 5.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first, second and third trimesters.The pregnancy outcome was reported as a live birth.It was unknown whether the child was healthy.The reporter considered abdominal pain, anxiety, back pain, complication of device insertion, cystitis, depression, dyspareunia, embedded device, fallopian tube perforation, fatigue, genital haemorrhage, headache, menorrhagia, menstrual cramp, migraine, pelvic pain, pregnancy with contraceptive device, psychological trauma, urinary tract infection, uterine perforation, vaginal discharge, vaginal haemorrhage, vaginal infection and menstrual cramps to be related to essure.The reporter commented: patient received treatment for pelvic pain, abdominal pain, dysmenorrhea (cramping) ,dyspareunia (painful sexual intercourse), general abnormal bleeding, psych injury, migration, perforation and vaginal infection.The tralling coils in the left ostia was 3.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6)2012: post essure procedure on the left with no spillage from the left tube.Apparent occluded right ostium to the right fallopian tube.Right fallopian tube not opacified.No spillage on the right.; on (b)(6) 2012: unilateral occlusion (left tube occluded).Imaging procedure - on (b)(6) 2012: essure confirmation test(s) (unspecified) bilateral occlusion.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: dysmenorrhea, dyspareunia, pelvic pain, vaginal discharge, vaginal haemorrhage, anxiety, migraine, embedded device, back pain.Lot number: 898925 manufacturing date: 2011-08 expiration date: 2014-08.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 9-jan-2020: pif received : new events were added: perforation: fallopian tube, event outcome and reporter information were updated.We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ('uterus perforation /migration of essure device -the metallic foreign body embedded in the region of the left cornu extending outside the uterus') and embedded device ('partially embedded in the (l) fallopian tube') in an adult female patient who had essure (batch no.898925) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective" and medical device monitoring error "no visible ostium to the right fallopian tube, and therefore, the essure procedure was only performed on the left".The patient's medical history included anemia, arthritis, parity 4 and miscarriage (3 miscarriages).Concomitant products included alprazolam, amitriptyline, bupropion hydrochloride (act bupropion xl), butalbital;caffeine;paracetamol (fioricet), clonazepam, ethinylestradiol;norethisterone acetate (loestrin), hydrocodone, nsaids, paracetamol (acetaminophen), rizatriptan and sumatriptan (imitrex).On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced pelvic pain ("pelvic pain"), dyspareunia ("dyspareunia painful sexual intercourse"), vaginal infection ("vaginal infection"), menorrhagia ("abnormal bleeding menorrhagia"), vaginal haemorrhage ("abnormal bleeding vaginal)), depression ("psychological or psychiatric problems - depression"), anxiety ("anxiety/mental anguish"), migraine ("migraines / headaches"), menstrual cramp ("dysmenorrhea cramping), vaginal discharge ("vaginal discharge") and fatigue ("fatigue").On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), genital haemorrhage ("general abnormal bleeding"), abdominal pain ("abdominal pain"), menstrual cramps ("dysmenorrhea cramping"), psychological trauma ("psych injury"), back pain ("lower back area pain"), headache ("headaches") and complication of device insertion ("complications or problems that occurred at the time of essure placement procedure-unable to visualized right ostia, so, inability to place essure") and was found to have a pregnancy with contraceptive device ("pregnancy no complication").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2019.At the time of the report, the uterine perforation, embedded device, pregnancy with contraceptive device, genital haemorrhage, abdominal pain, menstrual cramps, dyspareunia, psychological trauma, vaginal infection, menorrhagia, vaginal haemorrhage, depression, anxiety, migraine, menstrual cramp, fatigue and complication of device insertion outcome was unknown and the pelvic pain, back pain and headache was resolving.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 8, para 5.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first, second and third trimesters.The pregnancy outcome was reported as a live birth.It was unknown whether the child was healthy.The reporter considered abdominal pain, anxiety, back pain, complication of device insertion, depression, dyspareunia, embedded device, fatigue, genital haemorrhage, headache, menorrhagia, menstrual cramp, migraine, pelvic pain, pregnancy with contraceptive device, psychological trauma, uterine perforation, vaginal discharge, vaginal haemorrhage, vaginal infection and menstrual cramps to be related to essure.The reporter commented: patient received treatment for pelvic pain, abdominal pain, dysmenorrhea (cramping) ,dyspareunia (painful sexual intercourse), general abnormal bleeding, psych injury, migration, perforation and vaginal infection.The tralling coils in the left ostia was 3.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2012: post essure procedure on the left with no spillage from the left tube.Apparent occluded right ostium to the right fallopian tube.Right fallopian tube not opacified.No spillage on the right; on (b)(6) 2012: unilateral occlusion (left tube occluded).Imaging procedure - on (b)(6) 2012: essure confirmation test(s) (unspecified) bilateral occlusion.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: dysmenorrhea, dyspareunia, pelvic pain, vaginal discharge, vaginal haemorrhage, anxiety, migraine, embedded device, back pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 6-feb-2020: pfs and mr received.Reporter information, lot number, medical history, concomitant drugs added.Events: abnormal bleeding (vaginal, menorrhagia), psychological or psychiatric problems ¿ depression, anxiety, migraines / headaches, dysmenorrhea (cramping), vaginal discharge, fatigue, partially embedded in the (l) fallopian tube, lower back area pain, headaches,no visible ostium to the right fallopian tube, and therefore, the essure procedure was only performed on the left and complications or problems that occurred at the time of essure placement procedure-unable to visualized right ostia, so, inability to place essure were added.We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ('uterus perforation /migration of essure device -the metallic foreign body embedded in the region of the left cornu extending outside the uterus'), fallopian tube perforation ('perforation: fallopian tube') and embedded device ('partially embedded in the (l) fallopian tube') in a 35-year-old female patient who had essure (batch no.898925) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: medical device monitoring error "no visible ostium to the right fallopian tube, and therefore, the essure procedure was only performed on the left" and device ineffective "device ineffective".The patient's medical history included anemia, arthritis, parity 4 and miscarriage (3 miscarriages).Concomitant products included alprazolam, amitriptyline, bupropion hydrochloride (act bupropion xl), butalbital;caffeine;paracetamol (fioricet), clonazepam, ethinylestradiol;norethisterone acetate (loestrin), hydrocodone, nsaids, paracetamol (acetaminophen), rizatriptan and sumatriptan (imitrex).On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced pelvic pain ("pelvic pain"), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal infection ("vaginal infection"), menorrhagia ("abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), depression ("psychological or psychiatric problems - depression"), anxiety ("anxiety/mental anguish"), migraine ("migraines / headaches"), menstrual cramp ("dysmenorrhea (cramping)"), vaginal discharge ("vaginal discharge") and fatigue ("fatigue").On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criterion medically significant), embedded device (seriousness criteria medically significant and intervention required), genital haemorrhage ("general abnormal bleeding"), abdominal pain ("abdominal pain"), menstrual cramps ("dysmennorhea (cramping)"), psychological trauma ("psych injury"), back pain ("lower back area pain"), headache ("headaches"), complication of device insertion ("complications or problems that occurred at the time of essure placement procedure-unable to visualized right ostia, so, inability to place essure"), urinary tract infection ("urinary problems: uti") and cystitis ("bladder problem- bladder infection") and was found to have a pregnancy with contraceptive device ("pregnancy (no complication)").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2019.At the time of the report, the uterine perforation, fallopian tube perforation, embedded device, pregnancy with contraceptive device, psychological trauma, menorrhagia, vaginal haemorrhage, depression, anxiety, migraine, menstrual cramp, fatigue and complication of device insertion outcome was unknown, the genital haemorrhage, pelvic pain, abdominal pain, menstrual cramps, dyspareunia, vaginal infection, vaginal discharge, urinary tract infection and cystitis had resolved and the back pain and headache was resolving.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 8, para 5.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first, second and third trimesters.The pregnancy outcome was reported as a live birth.It was unknown whether the child was healthy.The reporter considered abdominal pain, anxiety, back pain, complication of device insertion, cystitis, depression, dyspareunia, embedded device, fallopian tube perforation, fatigue, genital haemorrhage, headache, menorrhagia, menstrual cramp, migraine, pelvic pain, pregnancy with contraceptive device, psychological trauma, urinary tract infection, uterine perforation, vaginal discharge, vaginal haemorrhage, vaginal infection and menstrual cramps to be related to essure.The reporter commented: patient received treatment for pelvic pain, abdominal pain, dysmennorhea (cramping) ,dyspareunia (painful sexual intercourse), general abnormal bleeding, psych injury, migration, perforation and vaginal infection.The tralling coils in the left ostia was 3.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2012: post essure procedure on the left with no spillage from the left tube.Apparent occluded right ostium to the right fallopian tube.Right fallopian tube not opacified.No spillage on the right.; on (b)(6) 2012: unilateral occlusion (left tube occluded).Imaging procedure - on (b)(6) 2012: essure confirmation test(s) (unspecified) bilateral occlusion.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: dysmenorrhea, dyspareunia, pelvic pain, vaginal discharge, vaginal haemorrhage, anxiety, migraine, embedded device, back pain lot number: 898925.Manufacturing date: 2011-08.Expiration date: 2014-08.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020: 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 uterine perforation ('uterus perforation /migration of essure device -the metallic foreign body embedded in the region of the left cornu extending outside the uterus'), fallopian tube perforation ('perforation: fallopian tube') and embedded device ('partially embedded in the (l) fallopian tube') in a 35-year-old female patient who had essure (batch no.898925) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: medical device monitoring error "no visible ostium to the right fallopian tube, and therefore, the essure procedure was only performed on the left" and device ineffective "device ineffective".The patient's medical history included anemia, arthritis, parity 4, miscarriage (3 miscarriages), low back pain, nausea and miscarriage.Previously administered products included for an unreported indication: losertin and kenalog.Concomitant products included alprazolam, amitriptyline, bupropion hydrochloride (act bupropion xl), butalbital;caffeine;paracetamol (fioricet), clonazepam, ethinylestradiol;norethisterone acetate (loestrin), hydrocodone, ibuprofen, nsaids, paracetamol (acetaminophen), rizatriptan and sumatriptan (imitrex).On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced pelvic pain ("pelvic pain"), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal infection ("vaginal infection"), heavy menstrual bleeding ("abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), depression ("psychological or psychiatric problems - depression"), anxiety ("anxiety/mental anguish"), migraine ("migraines / headaches"), menstrual cramp ("dysmenorrhea (cramping)"), vaginal discharge ("vaginal discharge") and fatigue ("fatigue").On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criterion medically significant), embedded device (seriousness criteria medically significant and intervention required), genital haemorrhage ("general abnormal bleeding"), abdominal pain ("abdominal pain"), menstrual cramps ("dysmennorhea (cramping)"), psychological trauma ("psych injury"), back pain ("lower back area pain"), headache ("headaches"), complication of device insertion ("complications or problems that occurred at the time of essure placement procedure-unable to visualized right ostia, so, inability to place essure"), urinary tract infection ("urinary problems: uti") and cystitis ("bladder problem- bladder infection") and was found to have a pregnancy with contraceptive device ("pregnancy (no complication)").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2019.At the time of the report, the uterine perforation, fallopian tube perforation, embedded device, pregnancy with contraceptive device, psychological trauma, heavy menstrual bleeding, vaginal haemorrhage, depression, anxiety, migraine, menstrual cramp, fatigue and complication of device insertion outcome was unknown, the genital haemorrhage, pelvic pain, abdominal pain, menstrual cramps, dyspareunia, vaginal infection, vaginal discharge, urinary tract infection and cystitis had resolved and the back pain and headache was resolving.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 8, para 5.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first, second and third trimesters.The pregnancy outcome was reported as a live birth.It was unknown whether the child was healthy.The reporter considered abdominal pain, anxiety, back pain, complication of device insertion, cystitis, depression, dyspareunia, embedded device, fallopian tube perforation, fatigue, genital haemorrhage, headache, heavy menstrual bleeding, menstrual cramp, migraine, pelvic pain, pregnancy with contraceptive device, psychological trauma, urinary tract infection, uterine perforation, vaginal discharge, vaginal haemorrhage, vaginal infection and menstrual cramps to be related to essure.The reporter commented: patient received treatment for pelvic pain, abdominal pain, dysmennorhea (cramping) ,dyspareunia (painful sexual intercourse), general abnormal bleeding, psych injury, migration, perforation and vaginal infection.The tralling coils in the left ostia was 3.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2012: post essure procedure on the left with no spillage from the left tube.Apparent occluded right ostium to the right fallopian tube.Right fallopian tube not opacified.No spillage on the right.; on (b)(6) 2012: unilateral occlusion (left tube occluded).Imaging procedure - on (b)(6) 2012: essure confirmation test(s) (unspecified) bilateral occlusion.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: dysmenorrhea, dyspareunia, pelvic pain, vaginal discharge, vaginal haemorrhage, anxiety, migraine, embedded device, back pain lot number: 898925, manufacturing date: 2011-08, and expiration date: 2014-08.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 13-may-2021: medical record received: medical history, reporter information were 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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