| Model Number ESS305 |
| Device Problems
Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Anemia (1706); Cyst(s) (1800); Fatigue (1849); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Pain (1994); Cramp(s) (2193); Depression (2361); No Information (3190); Genital Bleeding (4507)
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| Event Date 01/01/2008 |
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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 dysfunctional uterine bleeding ("dub(dysfuntional uterine bleeding)") in a female patient who had essure (batch no.624832, 624832) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included endometriosis.Concurrent conditions included anemia, tendonitis, depression, suicide attempt, anhedonia, irritable, loss of energy and cyst of ovary.Concomitant products included citalopram hydrobromide (celexa), docusate sodium, oral contraceptive nos and temazepam.On (b)(6) 2008, the patient had essure inserted.In 2008, the patient experienced dysfunctional uterine bleeding (seriousness criteria medically significant and intervention required), menorrhagia ("abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and dysmenorrhoea ("painful menstrual cycle/ dysmenorrhea (cramping)").In (b)(6) 2009, the patient experienced pelvic pain ("pelvic pain/ pain").On an unknown date, the patient experienced allergy to metals ("nickel allergy"), abdominal pain lower ("excessive cramping"), abdominal pain ("abdominal pain"), suprapubic pain ("suprapubic pain"), back pain ("back pain") and abdominal distension ("gastrointestinal or digestive system condition ¿ bloating").The patient was treated with surgery (excellent ablative effect seen after novasure (endometrial ablation novasure.)).Essure treatment was not changed.At the time of the report, the dysfunctional uterine bleeding, menorrhagia, pelvic pain, vaginal haemorrhage, allergy to metals, dysmenorrhoea, abdominal pain lower, abdominal pain, suprapubic pain, back pain and abdominal distension outcome was unknown.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, allergy to metals, back pain, dysfunctional uterine bleeding, dysmenorrhoea, menorrhagia, pelvic pain, suprapubic pain and vaginal haemorrhage to be related to essure.The reporter commented: it was reported that she wishes to proceed with novasure endometrial ablation.On normal hysteroscopy essure device was seen on the right side, not visible on the left.Excellent ablative effect seen after novasure.Moles appear benign, sent for path.Insertion date discrepancy: (b)(6) 2008.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2008: total bilateral occlusion.Event dub was added from the medical records.Most recent follow-up information incorporated above includes: on (b)(6) 2018: pfs and mr received:- reporters added and updated patient demographics.Concomitant disease laboratory data and concomitant drugs were added.Updated suspect drug inaction and lot number.On (b)(6) 2008, she implanted essure (previously reported as (b)(6) 2008).Added events abnormal bleeding (vaginal, menorrhagia), gastrointestinal or digestive system condition ¿ bloating, suprapubic pain.Event dub added from the medical records.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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Ntaneous case was reported by a lawyer and describes the occurrence of dysfunctional uterine bleeding ("dub(dysfuntional uterine bleeding)") in a 36-year-old female patient who had essure (batch no.624832) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included endometriosis.Previously administered products included for an unreported indication: prenatal vitamin and nor qd.Concurrent conditions included anemia, tendonitis, depression, suicide attempt, anhedonia, irritable, loss of energy and cyst of ovary.Concomitant products included cilest (sprintec), citalopram hydrobromide (celexa), docusate sodium, oral contraceptive nos and temazepam.On (b)(6) 2008, the patient had essure inserted.In 2008, the patient experienced dysfunctional uterine bleeding (seriousness criteria medically significant and intervention required).On (b)(6) 2008, 6 months after insertion of essure, the patient experienced menorrhagia ("abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and dysmenorrhoea ("painful menstrual cycle/ dysmenorrhea (cramping)").On (b)(6) 2009, the patient experienced abdominal distension ("gastrointestinal or digestive system condition ¿ bloating").In september 2009, the patient experienced pelvic pain ("pelvic pain/ pain").On an unknown date, the patient experienced allergy to metals ("nickel allergy"), abdominal pain lower ("excessive cramping"), abdominal pain ("abdominal pain"), suprapubic pain ("suprapubic pain"), back pain ("back pain") and vulvovaginal pain ("vaginal pain").The patient was treated with surgery (excellent ablative effect seen after novasure (endometrial ablation novasure).Essure treatment was not changed.At the time of the report, the dysfunctional uterine bleeding, menorrhagia, pelvic pain, vaginal haemorrhage, allergy to metals, dysmenorrhoea, abdominal pain lower, abdominal pain, suprapubic pain, back pain, abdominal distension and vulvovaginal pain outcome was unknown.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, allergy to metals, back pain, dysfunctional uterine bleeding, dysmenorrhoea, menorrhagia, pelvic pain, suprapubic pain, vaginal haemorrhage and vulvovaginal pain to be related to essure.The reporter commented: it was reported that she wishes to proceed with novasure endometrial ablation.On normal hysteroscopy essure device was seen on the right side, not visible on the left.Excellent ablative effect seen after novasure.Moles appear benign, sent for path.Insertion date discrepancy-??-may-2008.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on 15-aug-2008: total bilateral occlusion.Event dub was added from the medical records.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 13-aug-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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Ntaneous case was reported by a lawyer and describes the occurrence of dysfunctional uterine bleeding ("dub(dysfuntional uterine bleeding)") in a 36-year-old female patient who had essure (batch no.624832) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included endometriosis.Previously administered products included for an unreported indication: prenatal vitamin and nor qd.Concurrent conditions included anemia, tendonitis, depression, suicide attempt, anhedonia, irritable, loss of energy and cyst of ovary.Concomitant products included cilest (sprintec), citalopram hydrobromide (celexa), docusate sodium, oral contraceptive nos and temazepam.On (b)(6) 2008, the patient had essure inserted.In 2008, the patient experienced dysfunctional uterine bleeding (seriousness criteria medically significant and intervention required).On (b)(6) 2008, 6 months after insertion of essure, the patient experienced menorrhagia ("abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and dysmenorrhoea ("painful menstrual cycle/ dysmenorrhea (cramping)").On (b)(6) 2009, the patient experienced abdominal distension ("gastrointestinal or digestive system condition ¿ bloating").In (b)(6) 2009, the patient experienced pelvic pain ("pelvic pain/ pain").On an unknown date, the patient experienced allergy to metals ("nickel allergy"), abdominal pain lower ("excessive cramping"), abdominal pain ("abdominal pain"), suprapubic pain ("suprapubic pain"), back pain ("back pain") and vulvovaginal pain ("vaginal pain").The patient was treated with surgery (excellent ablative effect seen after novasure (endometrial ablation novasure.)).Essure treatment was not changed.At the time of the report, the dysfunctional uterine bleeding, menorrhagia, pelvic pain, vaginal haemorrhage, allergy to metals, dysmenorrhoea, abdominal pain lower, abdominal pain, suprapubic pain, back pain, abdominal distension and vulvovaginal pain outcome was unknown.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, allergy to metals, back pain, dysfunctional uterine bleeding, dysmenorrhoea, menorrhagia, pelvic pain, suprapubic pain, vaginal haemorrhage and vulvovaginal pain to be related to essure.The reporter commented: it was reported that she wishes to proceed with novasure endometrial ablation.On normal hysteroscopy essure device was seen on the right side, not visible on the left.Excellent ablative effect seen after novasure.Moles appear benign, sent for path.Insertion date discrepancy(b)(6) 2008.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2008: total bilateral occlusion.Event dub was added from the medical records.Most recent follow-up information incorporated above includes: on 1-aug-2018: plaintiff fact sheet received.Event vaginal pain was added.Historical, concomitant conditions and drugs were added.Lab data updated.Product, patient & reporter information updated.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 pelvic pain ('pelvic pain/ pain') and abnormal uterine bleeding ('dub(dysfuntional uterine bleeding)') in a 36-year-old female patient who had essure (batch no.624832) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included endometriosis and d & c.Previously administered products included for an unreported indication: prenatal vitamin and nor qd.Concurrent conditions included anemia, tendonitis, depression, suicide attempt, anhedonia, irritable, loss of energy, cyst of ovary, allergic rhinitis, depressive disorder, uterine bleeding, cervix inflammation, nabothian cyst and adenomyosis.Concomitant products included docusate sodium, ethinylestradiol;norgestimate (sprintec), oral contraceptive nos and temazepam.On (b)(6) 2008, the patient had essure inserted.In 2008, the patient experienced abnormal uterine bleeding (seriousness criteria medically significant and intervention required).On (b)(6) 2008, the patient experienced heavy menstrual bleeding ("abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and dysmenorrhoea ("painful menstrual cycle/ dysmenorrhea (cramping)"), 6 months after insertion of essure.On (b)(6) 2009, the patient experienced abdominal distension ("gastrointestinal or digestive system condition ¿ bloating").In (b)(6) 2009, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced allergy to metals ("nickel allergy"), abdominal pain lower ("excessive cramping"), abdominal pain ("abdominal pain"), suprapubic pain ("suprapubic pain"), back pain ("back pain") and vulvovaginal pain ("vaginal pain").The patient was treated with surgery (excellent ablative effect seen after novasure (endometrial ablation novasure.) and robot assisted total laparoscopic hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2021.At the time of the report, the pelvic pain, abnormal uterine bleeding, heavy menstrual bleeding, vaginal haemorrhage, allergy to metals, dysmenorrhoea, abdominal pain lower, abdominal pain, suprapubic pain, back pain, abdominal distension and vulvovaginal pain outcome was unknown.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, abnormal uterine bleeding, allergy to metals, back pain, dysmenorrhoea, heavy menstrual bleeding, pelvic pain, suprapubic pain, vaginal haemorrhage and vulvovaginal pain to be related to essure.The reporter commented: it was reported that she wishes to proceed with novasure endometrial ablation.On normal hysteroscopy essure device was seen on the right side, not visible on the left.Excellent ablative effect seen after novasure.Moles appear benign, sent for path.Insertion date discrepancy- (b)(6) 2008.Right: 2 coils left 2 coils.Plaintiff would like essure removed, but current insurance will not cover device removal.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2008: results: total bilateral occlusion.Event dub was added from the medical records.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 7-oct-2021: mr received.Essure removal details, reporter and medical history were added.Action taken with drug 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 pelvic pain ('pelvic pain/ pain') and abnormal uterine bleeding ('dub(dysfunctional uterine bleeding)') in a 36-year-old female patient who had essure (batch no.624832) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included endometriosis and d & c.Previously administered products included for an unreported indication: prenatal vitamin and nor qd.Concurrent conditions included anemia, tendonitis, depression, suicide attempt, anhedonia, irritable, loss of energy, cyst of ovary, allergic rhinitis, depressive disorder, uterine bleeding, cervix inflammation, nabothian cyst and adenomyosis.Concomitant products included docusate sodium, ethinylestradiol;norgestimate (sprintec), oral contraceptive nos and temazepam.On (b)(6) 2008, the patient had essure inserted.In 2008, the patient experienced abnormal uterine bleeding (seriousness criteria medically significant and intervention required).On (b)(6) 2008, the patient experienced heavy menstrual bleeding ("abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and dysmenorrhoea ("painful menstrual cycle/ dysmenorrhea (cramping)"), 6 months after insertion of essure.On (b)(6) 2009, the patient experienced abdominal distension ("gastrointestinal or digestive system condition ¿ bloating").In (b)(6) 2009, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced allergy to metals ("nickel allergy"), abdominal pain lower ("excessive cramping"), abdominal pain ("abdominal pain"), suprapubic pain ("suprapubic pain"), back pain ("back pain") and vulvovaginal pain ("vaginal pain").The patient was treated with surgery (excellent ablative effect seen after novasure (endometrial ablation novasure.) and robot assisted total laparoscopic hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2021.At the time of the report, the pelvic pain, abnormal uterine bleeding, heavy menstrual bleeding, vaginal haemorrhage, allergy to metals, dysmenorrhoea, abdominal pain lower, abdominal pain, suprapubic pain, back pain, abdominal distension and vulvovaginal pain outcome was unknown.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, abnormal uterine bleeding, allergy to metals, back pain, dysmenorrhoea, heavy menstrual bleeding, pelvic pain, suprapubic pain, vaginal haemorrhage and vulvovaginal pain to be related to essure.The reporter commented: it was reported that she wishes to proceed with novasure endometrial ablation.On normal hysteroscopy essure device was seen on the right side, not visible on the left.Excellent ablative effect seen after novasure.Moles appear benign, sent for path.Insertion date discrepancy - (b)(6) 2008 right: 2 coils left 2 coils.Plaintiff would like essure removed, but current insurance will not cover device removal.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2008: results: total bilateral occlusion.Lot number:624832 manufacturing date: 2007-06 expiration date: 2009-05.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 15-oct-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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