| Model Number ESS305 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Anemia (1706); Hemorrhage/Bleeding (1888); Pain (1994); Abdominal Cramps (2543); Heavier Menses (2666)
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| Event Date 02/01/2013 |
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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 ('physical pain/pelvic pain/chronic') and genital haemorrhage ('general abnormal.Bleeding') in an adult female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), abdominal pain ("abdominal pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), menorrhagia ("menorrhagia (heavy menstrual bleeding)"), anaemia ("anemia"), psychological trauma ("psych injury") and urinary tract disorder ("bladder/urinary problems: urinary problems").The patient was treated with surgery (essure removed by hysterectomy (full),salpingingectomy (bilateral) on (b)(6) 2018).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, genital haemorrhage, abdominal pain, dysmenorrhoea, menorrhagia, anaemia and urinary tract disorder had resolved and the psychological trauma outcome was unknown.The reporter considered abdominal pain, anaemia, dysmenorrhoea, genital haemorrhage, menorrhagia, pelvic pain, psychological trauma and urinary tract disorder to be related to essure.The reporter commented: patient reived treatment for- pain, bleeding and bladder/urinary problem.Discrepancy in date of insertion : in pervious follow up it was (b)(6) 2011 and this follow up it is 09-june-2013 diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: essure device was successfully occluded.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 4-sep-2019: pfs received: case became incident.Event was added- general abnormal.Bleeding ,abdominal pain , dysmenorrhea (cramping), menorrhagia (heavy menstrual bleeding), anemia, psych injury and urinary problems.Product start date and stop date 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 pelvic pain ('physical pain/pelvic pain/chronic/pelvic pain') and genital haemorrhage ('general abnormal, bleeding') in a 31-year-old female patient who had essure (batch no.A45108) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "plaintiff does not undergo essure confirmation test".The patient's medical history included nasal congestion, parity 3, multigravida, carpal tunnel syndrome, tonsillitis bacterial, dysfunctional uterine bleeding and uterine leiomyoma.Previously administered products included for an unreported indication: mirena.Concomitant products included ethinylestradiol;norethisterone acetate (loestrin), ethinylestradiol;norgestimate (ortho tri-cyclen) from (b)(6) 2012 to
(b)(6) 2018, ibuprofen since 2010, intrauterine contraceptive device (paragard) from
(b)(6) 2018 to (b)(6) 2018, medroxyprogesterone acetate (depo-provera) from (b)(6) 2012 to
(b)(6) 2013 and naproxen (motrin) since 2010.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain/abdominal pain"), menorrhagia ("menorrhagia (heavy menstrual bleeding)/abnormal bleeding (vaginal, menorrhagia),") and vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)").In (b)(6) 2013, the patient experienced depression ("psych injury/ psychological or psychiatric problems condition: depression") and anxiety ("psych injury/ psychological or psychiatric problems condition: mental anguish").On (b)(6) 2018, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)/dysmenorrhea (cramping)"), 5 years 6 months after insertion of essure.On an unknown date, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), anaemia ("anemia") and urinary tract disorder ("bladder/urinary problems: urinary problems").The patient was treated with surgery (ablation and total abdominal hysterectomy and bilat.Salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, genital haemorrhage, abdominal pain, dysmenorrhoea, menorrhagia, anaemia and urinary tract disorder had resolved and the vaginal haemorrhage, depression and anxiety outcome was unknown.The reporter considered abdominal pain, anaemia, anxiety, depression, dysmenorrhoea, genital haemorrhage, menorrhagia, pelvic pain, urinary tract disorder and vaginal haemorrhage to be related to essure.The reporter commented: patient reived treatment for- pain, bleeding and bladder/urinary problem.Discrepancy in date of insertion: in pervious follow up it was (b)(6) 2011 and this follow up it is (b)(6) 2013.Left: there were 3 coils outside of the tubal ostium, right:8 coils outside of the tubal ostium.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: essure device was successfully occluded.Ultrasound pelvis on (b)(6) 2018: bulky fibroid uterus.Lot number: a45108, manufacturing date: 2012/08, expiration date: 2015/08.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 7-oct-2019: quality safety evaluation of ptc (product technical complaint).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 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 pelvic pain ('physical pain/pelvic pain/chronic/pelvic pain') and genital haemorrhage ('general abnormal.Bleeding') in a 31-year-old female patient who had essure (batch no.A45108) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "plaintiff does not undergo essure confirmation test." the patient's medical history included nasal congestion, parity 3, multigravida, carpal tunnel syndrome, tonsillitis bacterial, dysfunctional uterine bleeding and uterine leiomyoma.Previously administered products included for an unreported indication: mirena.Concomitant products included ethinylestradiol;norethisterone acetate (loestrin), ethinylestradiol; norgestimate (ortho tri-cyclen) from (b)(6) 2012 to (b)(6) 2018, ibuprofen since 2010, intrauterine contraceptive device (paragard) from (b)(6) 2018, medroxyprogesterone acetate (depo-provera) from (b)(6) 2012 to (b)(6) 2013 and naproxen (motrin) since 2010.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain/abdominal pain"), menorrhagia ("menorrhagia (heavy menstrual bleeding)/abnormal bleeding (vaginal, menorrhagia),") and vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)").In (b)(6) 2013, the patient experienced depression ("psych injury/ psychological or psychiatric problems condition: depression") and anxiety ("psych injury/ psychological or psychiatric problems condition: mental anguish").On (b)(6) 2018, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)/dysmenorrhea (cramping)"), 5 years 6 months after insertion of essure.On an unknown date, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), anaemia ("anemia") and urinary tract disorder ("bladder/urinary problems: urinary problems").The patient was treated with surgery (ablation and total abdominal hysterectomy and bilat.Salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, genital haemorrhage, abdominal pain, dysmenorrhoea, menorrhagia, anaemia and urinary tract disorder had resolved and the vaginal haemorrhage, depression and anxiety outcome was unknown.The reporter considered abdominal pain, anaemia, anxiety, depression, dysmenorrhoea, genital haemorrhage, menorrhagia, pelvic pain, urinary tract disorder and vaginal haemorrhage to be related to essure.The reporter commented: patient received treatment for- pain, bleeding and bladder/urinary problem.Discrepancy in date of insertion : in pervious follow up it was (b)(6) 2011 and this follow up it is (b)(6) 2013.Left: there were 3 coils outside of the tubal ostium, right:8 coils outside of the tubal ostium.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: essure device was successfully occluded.Ultrasound pelvis - on (b)(6) 2018: bulky fibroid uterus.Most recent follow-up information incorporated above includes: on 12-sep-2019: pfs and mr received.Events per pfs: vaginal bleeding, depression and anxiety were clubbed with previously reported psych injury, plaintiff did not underwent essure confirmation test were added.Patient's medical history and concomitant medications were added.Lot number received.Incident: 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 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 pelvic pain ('physical pain/pelvic pain/chronic') and genital haemorrhage ('general abnormal bleeding') in a 31-year-old female patient who had essure (batch no.A45108) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "plaintiff does not undergo essure confirmation test".The patient's medical history included nasal congestion, parity 3, multigravida, carpal tunnel syndrome, tonsillitis bacterial, dysfunctional uterine bleeding and uterine leiomyoma.Previously administered products included for an unreported indication: mirena.Concomitant products included ethinylestradiol;norethisterone acetate (loestrin), ethinylestradiol;norgestimate (ortho tri-cyclen) from (b)(6) 2012 to (b)(6) 2018, ibuprofen since 2010, intrauterine contraceptive device (paragard) from (b)(6) 2018 to (b)(6) 2018, medroxyprogesterone acetate (depo-provera) from (b)(6) 2012 to (b)(6) 2013 and naproxen (motrin) since 2010.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain/abdominal pain"), menorrhagia ("menorrhagia (heavy menstrual bleeding)/abnormal bleeding (menorrhagia)") and vaginal haemorrhage ("abnormal bleeding (vaginal)").In (b)(6) 2013, the patient experienced depression ("psych injury/ psychological or psychiatric problems condition: depression") and anxiety ("psych injury/ psychological or psychiatric problems condition: mental anguish").On (b)(6) 2018, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)"), 5 years 6 months after insertion of essure.On an unknown date, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), anaemia ("anemia") and urinary tract disorder ("bladder/urinary problems: urinary problems").The patient was treated with surgery (ablation and total abdominal hysterectomy and bilat.Salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, genital haemorrhage, abdominal pain, dysmenorrhoea, menorrhagia, anaemia, urinary tract disorder and vaginal haemorrhage had resolved and the depression and anxiety outcome was unknown.The reporter considered abdominal pain, anaemia, anxiety, depression, dysmenorrhoea, genital haemorrhage, menorrhagia, pelvic pain, urinary tract disorder and vaginal haemorrhage to be related to essure.The reporter commented: patient reived treatment for- pain, bleeding and bladder/urinary problem.Discrepancy in date of insertion : in pervious follow up it was (b)(6) 2011 and this follow up it is (b)(6) 2013.Left: there were 3 coils outside of the tubal ostium, right:8 coils outside of the tubal ostium.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: essure device was successfully occluded.Ultrasound pelvis - on (b)(6) 2018: bulky fibroid uterus.Lot number: a45108 manufacturing date: 2012/08 expiration date: 2015/08.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 18-dec-2019: outcome of event vaginal haemorrhage was recovered.Based on the available information, a review of our complaint records and other relevant data will be 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 pelvic pain ('physical pain/pelvic pain/chronic') and genital haemorrhage ('general abnormal bleeding') in a 31-year-old female patient who had essure (batch no.A45108) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "plaintiff does not undergo essure confirmation test".The patient's medical history included nasal congestion, parity 3, multigravida, carpal tunnel syndrome, tonsillitis bacterial, dysfunctional uterine bleeding and uterine leiomyoma.Previously administered products included for an unreported indication: mirena.Concomitant products included ethinylestradiol;norethisterone acetate (loestrin), ethinylestradiol;norgestimate (ortho tri-cyclen) from (b)(6) 2012 to (b)(6) -2018, ibuprofen since 2010, intrauterine contraceptive device (paragard) from (b)(6) 2018, medroxyprogesterone acetate (depo-provera) from (b)(6) 2012 to (b)(6) 2013 and naproxen (motrin) since 2010.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain/abdominal pain"), menorrhagia ("menorrhagia (heavy menstrual bleeding)/abnormal bleeding (menorrhagia)") and vaginal haemorrhage ("abnormal bleeding (vaginal)").In (b)(6) 2013, the patient experienced depression ("psych injury/ psychological or psychiatric problems condition: depression") and anxiety ("psych injury/ psychological or psychiatric problems condition: mental anguish").On (b)(6) 2018, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)"), 5 years 6 months after insertion of essure.On an unknown date, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), anaemia ("anemia") and urinary tract disorder ("bladder/urinary problems: urinary problems").The patient was treated with surgery (ablation and total abdominal hysterectomy and bilat.Salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, genital haemorrhage, abdominal pain, dysmenorrhoea, menorrhagia, anaemia, urinary tract disorder and vaginal haemorrhage had resolved and the depression and anxiety outcome was unknown.The reporter considered abdominal pain, anaemia, anxiety, depression, dysmenorrhoea, genital haemorrhage, menorrhagia, pelvic pain, urinary tract disorder and vaginal haemorrhage to be related to essure.The reporter commented: patient received treatment for- pain, bleeding and bladder/urinary problem.Discrepancy in date of insertion : in pervious follow up it was (b)(6) 2011 and this follow up it is (b)(6) 2013.Left: there were 3 coils outside of the tubal ostium, right:8 coils outside of the tubal ostium.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: essure device was successfully occluded.Ultrasound pelvis - on (b)(6) 2018: bulky fibroid uterus.Lot number: a45108, manufacturing date: 2012/08, expiration date: 2015/08.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 18-dec-2019: outcome of event vaginal haemorrhage was recovered.Based on the available information, a review of our complaint records and other relevant data will be 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 pelvic pain ('physical pain/pelvic pain/chronic') and genital haemorrhage ('general abnormal bleeding') in a 31-year-old female patient who had essure (batch no.A45108) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "plaintiff does not undergo essure confirmation test".The patient's medical history included nasal congestion, parity 3, multigravida, carpal tunnel syndrome, tonsillitis bacterial, dysfunctional uterine bleeding and uterine leiomyoma.Previously administered products included for an unreported indication: mirena.Concomitant products included ethinylestradiol;norethisterone acetate (loestrin), ethinylestradiol;norgestimate (ortho tri-cyclen) from 4-dec-2012 to 6-aug-2018, ibuprofen since 2010, intrauterine contraceptive device (paragard) from 21-aug-2018 to 21-aug-2018, medroxyprogesterone acetate (depo-provera) from 1-dec-2012 to 1-apr-2013 and naproxen (motrin) since 2010.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain/abdominal pain"), menorrhagia ("menorrhagia (heavy menstrual bleeding)/abnormal bleeding (menorrhagia)") and vaginal haemorrhage ("abnormal bleeding (vaginal)").In (b)(6) 2013, the patient experienced depression ("psych injury/ psychological or psychiatric problems condition: depression") and anxiety ("psych injury/ psychological or psychiatric problems condition: mental anguish").On (b)(6) 2018, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)"), 5 years 6 months after insertion of essure.On an unknown date, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), anaemia ("anemia") and urinary tract disorder ("bladder/urinary problems: urinary problems").The patient was treated with surgery (ablation and total abdominal hysterectomy and bilat.Salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, genital haemorrhage, abdominal pain, dysmenorrhoea, menorrhagia, anaemia, urinary tract disorder and vaginal haemorrhage had resolved and the depression and anxiety outcome was unknown.The reporter considered abdominal pain, anaemia, anxiety, depression, dysmenorrhoea, genital haemorrhage, menorrhagia, pelvic pain, urinary tract disorder and vaginal haemorrhage to be related to essure.The reporter commented: patient reived treatment for- pain, bleeding and bladder/urinary problem.Discrepancy in date of insertion : in pervious follow up it was (b)(6) 2011 and this follow up it is (b)(6) 2013.Left: there were 3 coils outside of the tubal ostium, right:8 coils outside of the tubal ostium.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: essure device was successfully occluded.Ultrasound pelvis - on (b)(6) 2018: bulky fibroid uterus.Lot number: a45108.Manufacturing date: 2012/08.Expiration date: 2015/08.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2019: outcome of event vaginal haemorrhage was recovered.Based on the available information, a review of our complaint records and other relevant data will be 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 pelvic pain ('physical pain/pelvic pain/chronic') and genital haemorrhage ('general abnormal bleeding') in a 31-year-old female patient who had essure (batch no.A45108) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "plaintiff does not undergo essure confirmation test".The patient's medical history included nasal congestion, parity 3, multigravida, carpal tunnel syndrome, tonsillitis bacterial, dysfunctional uterine bleeding and uterine leiomyoma.Previously administered products included for an unreported indication: mirena.Concomitant products included ethinylestradiol;norethisterone acetate (loestrin), ethinylestradiol;norgestimate (ortho tri-cyclen) from (b)(6) 2012 to (b)(6) 2018, ibuprofen since 2010, intrauterine contraceptive device (paragard) from (b)(6) 2018 to (b)(6) 2018, medroxyprogesterone acetate (depo-provera) from (b)(6) 2012 to (b)(6) 2013 and naproxen (motrin) since 2010.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain/abdominal pain"), menorrhagia ("menorrhagia (heavy menstrual bleeding)/abnormal bleeding (menorrhagia)") and vaginal haemorrhage ("abnormal bleeding (vaginal)").In (b)(6) 2013, the patient experienced depression ("psych injury/ psychological or psychiatric problems condition: depression") and anxiety ("psych injury/ psychological or psychiatric problems condition: mental anguish").On (b)(6) 2018, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)"), 5 years 6 months after insertion of essure.On an unknown date, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), anaemia ("anemia") and urinary tract disorder ("bladder/urinary problems: urinary problems").The patient was treated with surgery (ablation and total abdominal hysterectomy and bilat.Salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, genital haemorrhage, abdominal pain, dysmenorrhoea, menorrhagia, anaemia, urinary tract disorder and vaginal haemorrhage had resolved and the depression and anxiety outcome was unknown.The reporter considered abdominal pain, anaemia, anxiety, depression, dysmenorrhoea, genital haemorrhage, menorrhagia, pelvic pain, urinary tract disorder and vaginal haemorrhage to be related to essure.The reporter commented: patient reived treatment for- pain, bleeding and bladder/urinary problem.Discrepancy in date of insertion : in pervious follow up it was (b)(6) 2011 and this follow up it is (b)(6) 2013.Left: there were 3 coils outside of the tubal ostium, right:8 coils outside of the tubal ostium.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: essure device was successfully occluded.Ultrasound pelvis - on (b)(6) 2018: bulky fibroid uterus.Lot number: a45108 manufacturing date: 2012/08 expiration date: 2015/08.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 22-jul-2020: quality safety evaluation of ptc (product technical complaint).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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