| Model Number ESS305 |
| Device Problems
Break (1069); Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978); Insufficient Information (3190)
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| Patient Problems
Uterine Perforation (2121); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 06/26/2015 |
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Event Type
malfunction
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Event Description
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('essure dislocation'), embedded device ('essure in endometriun') and device breakage ('essure was found fragmented in many parts') in a (b)(6) female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.The patient's medical history included pregnancy and multigravida.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2015, the patient experienced procedural pain ("pain in the lower abdomen").In 2017, the patient experienced migraine with aura ("migraine with aura"), nausea ("nausea") and pain in extremity ("lower limb pain").On (b)(6) 2020, the patient experienced embedded device (seriousness criterion medically significant).On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), device breakage (seriousness criterion medically significant), polymenorrhagia ("increased flow and frequency of menstruation (hypermenorrhea)"), dysmenorrhoea ("severe pain during menstrual flow"), dyspareunia ("pain during intercourse"), vaginal discharge ("increased vaginal secretion with odor and pruritus"), vulvovaginal pruritus ("increased vaginal secretion with odor and pruritus"), urinary tract infection ("recurrent uti"), diarrhoea ("sporadic intermittent diarrhea") and anxiety disorder ("anxiety disorder").The patient was treated with analgesics and antiinflammatory agents.Essure treatment was ongoing at the time of the report.On (b)(6) 2015, the procedural pain had resolved.At the time of the report, the device dislocation and embedded device had not resolved and the device breakage, migraine with aura, nausea, pain in extremity, polymenorrhagia, dysmenorrhoea, dyspareunia, vaginal discharge, vulvovaginal pruritus, urinary tract infection, diarrhoea and anxiety disorder outcome was unknown.The reporter considered anxiety disorder, device breakage, device dislocation, diarrhoea, dysmenorrhoea, dyspareunia, embedded device, migraine with aura, nausea, pain in extremity, polymenorrhagia, procedural pain, urinary tract infection, vaginal discharge and vulvovaginal pruritus to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): blood heavy metal test (0.6 - 7.5 mcg/l) - on (b)(6) 2019: 4.65 mcg/l.Human chorionic gonadotropin - on (b)(6) 2015: negative.Magnetic resonance imaging abdominal - on (b)(6) 2019: essure present; on (b)(6) 2020: essure present.Ultrasound scan - on (b)(6) 2020: essure in endometrium.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 device dislocation ('essure dislocation'), embedded device ('essure in endometrium') and device breakage ('essure was found fragmented in many parts') in a 39-year-old female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.The patient's medical history included gravida ii and multigravida.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2015, the patient experienced procedural pain ("pain in the lower abdomen").In 2017, the patient experienced migraine with aura ("migraine with aura"), nausea ("nausea"), pain in extremity ("lower limb pain") and back pain ("lumbar pain").On (b)(6) 2020, the patient experienced embedded device (seriousness criterion medically significant).On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), device breakage (seriousness criterion medically significant), polymenorrhagia ("increased flow and frequency of menstruation (hypermenorrhea)"), dysmenorrhoea ("severe pain during menstrual flow"), dyspareunia ("pain during intercourse"), vaginal discharge ("increased vaginal secretion with odor and pruritus"), vulvovaginal pruritus ("increased vaginal secretion with odor and pruritus"), urinary tract infection ("recurrent uti"), diarrhoea ("sporadic intermittent diarrhea") and anxiety disorder ("anxiety disorder").The patient was treated with analgesics and antiinflammatory agents.Essure treatment was ongoing at the time of the report.On (b)(6) 2015, the procedural pain had resolved.At the time of the report, the device dislocation and embedded device had not resolved and the device breakage, migraine with aura, nausea, pain in extremity, polymenorrhagia, dysmenorrhoea, dyspareunia, vaginal discharge, vulvovaginal pruritus, urinary tract infection, diarrhoea, anxiety disorder and back pain outcome was unknown.The reporter considered anxiety disorder, back pain, device breakage, device dislocation, diarrhoea, dysmenorrhoea, dyspareunia, embedded device, migraine with aura, nausea, pain in extremity, polymenorrhagia, procedural pain, urinary tract infection, vaginal discharge and vulvovaginal pruritus to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): blood heavy metal test (0.6 - 7.5 mcg/l) - on (b)(6) 2019: 4.65 mcg/l.Human chorionic gonadotropin - on (b)(6) 2015: negative.Magnetic resonance imaging abdominal - on (b)(6) 2019: essure present; on (b)(6) 2020: essure present.Ultrasound scan - on (b)(6) 2020: essure in endometrium.X-ray - on (b)(6) 2020: essure dislocated, in eminence of to perforate the internal organs.Essure fragmented in several parts.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 2-sep-2020: quality safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('essure dislocation'), embedded device ('essure in endometriun') and device breakage ('essure was found fragmented in many parts') in a 39-year-old female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.The patient's medical history included gravida ii and multigravida.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2015, the patient experienced procedural pain ("pain in the lower abdomen").In 2017, the patient experienced migraine with aura ("migraine with aura"), nausea ("nausea"), pain in extremity ("lower limb pain") and back pain ("lumbar pain").On (b)(6) 2020, the patient experienced embedded device (seriousness criterion medically significant).On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), device breakage (seriousness criterion medically significant), polymenorrhagia ("increased flow and frequency of menstruation (hypermenorrhea)"), dysmenorrhoea ("severe pain during menstrual flow"), dyspareunia ("pain during intercourse"), vaginal discharge ("increased vaginal secretion with odor and pruritus"), vulvovaginal pruritus ("increased vaginal secretion with odor and pruritus"), urinary tract infection ("recurrent uti"), diarrhoea ("sporadic intermittent diarrhea") and anxiety disorder ("anxiety disorder").The patient was treated with analgesics and antiinflammatory agents.Essure treatment was ongoing at the time of the report.On (b)(6) 2015, the procedural pain had resolved.At the time of the report, the device dislocation and embedded device had not resolved and the device breakage, migraine with aura, nausea, pain in extremity, polymenorrhagia, dysmenorrhoea, dyspareunia, vaginal discharge, vulvovaginal pruritus, urinary tract infection, diarrhoea, anxiety disorder and back pain outcome was unknown.The reporter considered anxiety disorder, back pain, device breakage, device dislocation, diarrhoea, dysmenorrhoea, dyspareunia, embedded device, migraine with aura, nausea, pain in extremity, polymenorrhagia, procedural pain, urinary tract infection, vaginal discharge and vulvovaginal pruritus to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): blood heavy metal test (0.6 - 7.5 mcg/l) - on (b)(6) 2019: 4.65 mcg/l.Human chorionic gonadotropin - on (b)(6) 2015: negative.Magnetic resonance imaging abdominal - on (b)(6) 2019: essure present; on (b)(6) 2020: essure present.Ultrasound scan - on (b)(6) 2020: essure in endometrium.X-ray - on (b)(6) 2020: essure dislocated, in eminence of to perforate the internal organs.Essure fragmented in several parts.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020: new event lumbar pain was added.Lab data was updated.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('essure dislocation'), embedded device ('essure in endometriun') and device breakage ('essure was found fragmented in many parts') in a 39-year-old female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.The patient's medical history included gravida ii and multigravida.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2015, the patient experienced procedural pain ("pain in the lower abdomen").In 2017, the patient experienced migraine with aura ("migraine with aura"), nausea ("nausea") and pain in extremity ("lower limb pain").On (b)(6) 2020, the patient experienced em20dded device (seriousness criterion medically significant).On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), device breakage (seriousness criterion medically significant), polymenorrhagia ("increased flow and frequency of menstruation (hypermenorrhea)"), dysmenorrhoea ("severe pain during menstrual flow"), dyspareunia ("pain during intercourse"), vaginal discharge ("increased vaginal secretion with odor and pruritus"), vulvovaginal pruritus ("increased vaginal secretion with odor and pruritus"), urinary tract infection ("recurrent uti"), diarrhoea ("sporadic intermittent diarrhea") and anxiety disorder ("anxiety disorder").The patient was treated with analgesics and antiinflammatory agents.Essure treatment was ongoing at the time of the report.On (b)(6) 2015, the procedural pain had resolved.At the time of the report, the device dislocation and embedded device had not resolved and the device breakage, migraine with aura, nausea, pain in extremity, polymenorrhagia, dysmenorrhoea, dyspareunia, vaginal discharge, vulvovaginal pruritus, urinary tract infection, diarrhoea and anxiety disorder outcome was unknown.The reporter considered anxiety disorder, device breakage, device dislocation, diarrhoea, dysmenorrhoea, dyspareunia, embedded device, migraine with aura, nausea, pain in extremity, polymenorrhagia, procedural pain, urinary tract infection, vaginal discharge and vulvovaginal pruritus to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): blood heavy metal test (0.6 - 7.5 mcg/l) - on (b)(6) 2019: 4.65 mcg/l.Human chorionic gonadotropin - on (b)(6) 2015: negative.Magnetic resonance imaging abdominal - on (b)(6) 2019: essure present; on (b)(6) 2020: essure present.Ultrasound scan - on (b)(6) 2020: essure in endometrium.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 6-aug-2020: quality-safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('essure dislocation'), embedded device ('essure in endometriun') and device breakage ('essure was found fragmented in many parts') in a 39-year-old female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.The patient's medical history included menarche (13 years-old) in 1994, gravida ii and parity 2.Previously administered products included for an unreported indication: microvilar.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2015, the patient experienced procedural pain ("pain in the lower abdomen"), pelvic pain ("pelvc pain"), fatigue ("fatigue") and headache ("headache").On (b)(6) 2015, the patient experienced embedded device (seriousness criterion medically significant).In 2017, the patient experienced migraine with aura ("migraine with aura"), nausea ("nausea"), pain in extremity ("lower limb pain") and back pain ("lumbar pain").On (b)(6) 2019, the patient experienced urinary tract infection ("urinary tract infection") with dysuria and haematuria.On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), device breakage (seriousness criterion medically significant), polymenorrhagia ("increased flow and frequency of menstruation (hypermenorrhea)"), dysmenorrhoea ("severe pain during menstrual flow"), dyspareunia ("pain during intercourse"), vaginal discharge ("increased vaginal secretion with odor and pruritus"), vulvovaginal pruritus ("increased vaginal secretion with odor and pruritus"), recurrent uti ("recurrent uti"), diarrhoea ("sporadic intermittent diarrhea") and anxiety disorder ("anxiety disorder").The patient was treated with analgesics and antiinflammatory agents.Essure treatment was ongoing at the time of the report.On (b)(6) 2015, the procedural pain had resolved.At the time of the report, the device dislocation, embedded device, recurrent uti and urinary tract infection had not resolved and the device breakage, migraine with aura, nausea, pain in extremity, polymenorrhagia, dysmenorrhoea, dyspareunia, vaginal discharge, vulvovaginal pruritus, diarrhoea, anxiety disorder, back pain, pelvic pain, fatigue and headache outcome was unknown.The reporter considered anxiety disorder, back pain, device breakage, device dislocation, diarrhoea, dysmenorrhoea, dyspareunia, embedded device, fatigue, headache, migraine with aura, nausea, pain in extremity, pelvic pain, polymenorrhagia, procedural pain, urinary tract infection, vaginal discharge, vulvovaginal pruritus and recurrent uti to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): blood creatine (0.70 - 1.20 mg/dl) - on (b)(6) 2019: 0.93 mg/dl.Blood heavy metal test (0.6 - 7.5 mcg/l) - on (b)(6) 2019: 4.65 mcg/l.Blood potassium (3.6 - 5.0 meq/l) - on (b)(6) 2019: 4.7 meq/l.Blood sodium (135.0 - 148.0 meq/l) - on (b)(6) 2019: 139.7 meq/l.Eosinophil percentage (1.0 - 5.0 %) - on (b)(6) 2019: 0.5 %.Gynaecological examination - on (b)(6) 2019: flabby abdomen, painful on palpation of the flank, absence of masses palpable.Pubic of conformation and gynecoid quantity.Trophic vulva, with large and small lips with normal dimensions without changes.Specular examination showed a neck with jec 0 without ulcers or polyps.Vaginal discharge with a characteristic and habitual appearance, color and odor.Vaginal touch, mobile uterus in retroversoflexion, with regular surface and normal dimensions.Haematocrit (37.0 - 44.0 %) - on (b)(6) 2020: 44.2 %.Human chorionic gonadotropin - on (b)(6) 2015: negative.Lymphocyte percentage (20.0 - 50.0 %) - on (b)(6) 2019: 17.4 %.Magnetic resonance imaging abdominal - on (b)(6) 2019: essure present; on (b)(6) 2020: essure present.Mean cell haemoglobin (27.0 - 32.0 pg) - on (b)(6) 2020: 26.8 pg.Neutrophil count - on (b)(6) 2019: 9.1.Neutrophil percentage (40.0 - 74.0 %) - on (b)(6) 2019: 76.2 %.Red blood cell count (3.90 - 5.30 10 thousand per microlitre) - on (b)(6) 2020: 5.41 10 thousand per microlitre.Red cell distribution width (12.0 - 17.0 %) - on (b)(6) 2019: 11.5 %; on (b)(6) 2020: 11.9 %.Ultrasound abdomen - on (b)(6) 2017: unremarkable.Ultrasound scan - on (b)(6) 2015: essure in the regions of the uterine horns, linear on the right and circular on the left embedded in the myometrium; on (b)(6) 2018: uterine 93 cc, endometrium 6mm, right ovarian 4.7 cc, left ovarian 11.1 cc; on (b)(6) 2020: essure in endometrium.White blood cell count (4.0 - 11.0 10*3/ul) - on (b)(6) 2019: 11.9 10*3/ul.X-ray - on (b)(6) 2019: presence of metallic device; on (b)(6) 2020: essure dislocated, in eminence of to perforate the internal organs.Essure fragmented in several parts.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 16-apr-2021: the initial case (b)(4) was transferred to this case, the follow information were updated, new reporter, medical history, lab data, pelvic pain, fatigue, headache, urinary tract infection.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('essure dislocation'), embedded device ('essure in endometrium') and device breakage ('essure was found fragmented in many parts') in a 39-year-old female patient who had essure (batch no.B02267) inserted for contraception.The occurrence of additional non-serious events is detailed below.The patient's medical history included menarche (13 years-old) in 1994, gravida ii and parity 2.Previously administered products included for an unreported indication: microvillar.Concomitant products included drospirenone + ethinylestradiol-beta-cyclodextrin (yaz flex).On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2015, the patient experienced procedural pain ("pain in the lower abdomen"), pelvic pain ("pelvc pain, colic pain, stitches pain, pelvic pain since insertion"), fatigue ("fatigue") and headache ("headache").On (b)(6) 2015, the patient experienced embedded device (seriousness criterion medically significant).In 2017, the patient experienced migraine with aura ("migraine with aura"), nausea ("nausea"), pain in extremity ("lower limb pain"), polymenorrhagia ("increased flow and frequency of menstruation (hypermenorrhea)"), dysmenorrhoea ("severe pain during menstrual flow"), dyspareunia ("pain during intercourse"), vaginal discharge ("increased vaginal secretion with odor and pruritus"), vulvovaginal pruritus ("increased vaginal secretion with odor and pruritus"), recurrent uti ("recurrent uti"), diarrhoea ("sporadic intermittent diarrhea"), anxiety disorder ("anxiety disorder"), back pain ("lumbar pain") and vomiting ("vomiting").On (b)(6) 2019, the patient experienced haematuria ("haematuria") and dysuria ("dysuria").On (b)(6) 2019, the patient experienced urinary tract infection ("urinary tract infection") with dysuria, haematuria and pelvic pain.On (b)(6) 2020, the patient experienced heavy menstrual bleeding ("considerable and intense increase in menstrual flow, reaching up to 15 (fifteen) days").On (b)(6) 2020, the patient experienced intermenstrual bleeding ("metrorrhagia").On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant) and device breakage (seriousness criterion medically significant).The patient was treated with analgesics and antiinflammatory agents.Essure treatment was ongoing at the time of the report.On (b)(6) 2015, the procedural pain had resolved.At the time of the report, the device dislocation, embedded device, recurrent uti, urinary tract infection and pelvic pain had not resolved and the device breakage, migraine with aura, nausea, pain in extremity, polymenorrhagia, dysmenorrhoea, dyspareunia, vaginal discharge, vulvovaginal pruritus, diarrhoea, anxiety disorder, back pain, fatigue, headache, vomiting, intermenstrual bleeding, haematuria, dysuria and heavy menstrual bleeding outcome was unknown.The reporter considered anxiety disorder, back pain, device breakage, device dislocation, diarrhoea, dysmenorrhoea, dyspareunia, dysuria, embedded device, fatigue, haematuria, headache, heavy menstrual bleeding, intermenstrual bleeding, migraine with aura, nausea, pain in extremity, pelvic pain, polymenorrhagia, procedural pain, recurrent uti, vaginal discharge, vomiting, vulvovaginal pruritus and urinary tract infection to be related to essure.No further causality assessment were provided for the product.The reporter commented: essure placement procedure was complicated, on left side endometrium obstruct the ostium, right side device was placed only on the 2nd trial.She complained of pelvic pain in outpatient clinics at (b)(6) 2020 and (b)(6) 2020.Diagnostic results (normal ranges are provided in parenthesis if available): blood creatine (0.70 - 1.20 mg/dl) - on (b)(6) 2019: 0.93 mg/dl.Blood heavy metal test (0.6 - 7.5 mcg/l) - on (b)(6) 2019: 4.65 mcg/l.Blood potassium (3.6 - 5.0 meq/l) - on (b)(6) 2019: 4.7 meq/l.Blood sodium (135.0 - 148.0 meq/l) - on (b)(6) 2019: 139.7 meq/l.Eosinophil percentage (1.0 - 5.0 %) - on (b)(6) 2019: 0.5 %.Gynaecological examination - on (b)(6) 2019: flabby abdomen, painful on palpation of the flank, absence of masses palpable.Pubic of conformation and gynecoid quantity.Trophic vulva, with large and small lips with normal dimensions without changes.Specular examination showed a neck with jec 0 without ulcers or polyps.Vaginal discharge with a characteristic and habitual appearance, color and odor.Vaginal touch, mobile uterus in retroversoflexion, with regular surface and normal dimensions.Haematocrit (37.0 - 44.0 %) - on (b)(6) 2020: 44.2 %.Human chorionic gonadotropin - on (b)(6) 2015: negative.Lymphocyte percentage (20.0 - 50.0 %) - on (b)(6) 2019: 17.4 %.Magnetic resonance imaging abdominal - on (b)(6) 2019: essure present; on (b)(6) 2020: essure present.Mean cell haemoglobin (27.0 - 32.0 pg) - on (b)(6) 2020: 26.8 pg.Neutrophil count - on (b)(6) 2019: 9.1.Neutrophil percentage (40.0 - 74.0 %) - on (b)(6) 2019: 76.2 %.Red blood cell count (3.90 - 5.30 10 thousand per microlitre) - on (b)(6) 2020: 5.41 10 thousand per microlitre.Red cell distribution width (12.0 - 17.0 %) - on (b)(6) 2019: 11.5 %; on (b)(6) 2020: 11.9 %.Ultrasound abdomen - on (b)(6) 2017: unremarkable.Ultrasound scan - on (b)(6) 2015: essure in the regions of the uterine horns, linear on the right and circular on the left embedded in the myometrium; on (b)(6) 2018: uterine 93 cc, endometrium 6mm, right ovarian 4.7 cc, left ovarian 11.1 cc; on (b)(6) 2020: uterine 117.3 cc, endometrium 6mm, right ovarian 2.0 cc, left ovarian 15.2 cc.Essure in endometrium.White blood cell count (4.0 - 11.0 10*3/ul) - on (b)(6) 2019: 11.9 10*3/ul.X-ray - on (b)(6) 2019: presence of metallic device; on (b)(6) 2020: essure dislocated, in eminence of to perforate the internal organs.Essure fragmented in several parts.Lot number:b02267 manufacturing date: 2013-02 expiration date:2016-02 quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample could not be conducted, as no sample was available.Most recent follow-up information incorporated above includes: on (b)(6) 2021: quality safety evaluation of ptc we received a lot number in this case.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('essure dislocation'), embedded device ('essure in endometriun') and device breakage ('essure was found fragmented in many parts') in a 39-year-old female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.The patient's medical history included menarche (13 years-old) in 1994, gravida ii and parity 2.Previously administered products included for an unreported indication: microvilar.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2015, the patient experienced procedural pain ("pain in the lower abdomen"), pelvic pain ("pelvc pain"), fatigue ("fatigue") and headache ("headache").On (b)(6) 2015, the patient experienced embedded device (seriousness criterion medically significant).In 2017, the patient experienced migraine with aura ("migraine with aura"), nausea ("nausea"), pain in extremity ("lower limb pain") and back pain ("lumbar pain").On (b)(6) 2019, the patient experienced urinary tract infection ("urinary tract infection") with dysuria and haematuria.On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), device breakage (seriousness criterion medically significant), polymenorrhagia ("increased flow and frequency of menstruation (hypermenorrhea)"), dysmenorrhoea ("severe pain during menstrual flow"), dyspareunia ("pain during intercourse"), vaginal discharge ("increased vaginal secretion with odor and pruritus"), vulvovaginal pruritus ("increased vaginal secretion with odor and pruritus"), recurrent uti ("recurrent uti"), diarrhoea ("sporadic intermittent diarrhea") and anxiety disorder ("anxiety disorder").The patient was treated with analgesics and antiinflammatory agents.Essure treatment was ongoing at the time of the report.On (b)(6) 2015, the procedural pain had resolved.At the time of the report, the device dislocation, embedded device, recurrent uti and urinary tract infection had not resolved and the device breakage, migraine with aura, nausea, pain in extremity, polymenorrhagia, dysmenorrhoea, dyspareunia, vaginal discharge, vulvovaginal pruritus, diarrhoea, anxiety disorder, back pain, pelvic pain, fatigue and headache outcome was unknown.The reporter considered anxiety disorder, back pain, device breakage, device dislocation, diarrhoea, dysmenorrhoea, dyspareunia, embedded device, fatigue, headache, migraine with aura, nausea, pain in extremity, pelvic pain, polymenorrhagia, procedural pain, urinary tract infection, vaginal discharge, vulvovaginal pruritus and recurrent uti to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): blood creatine (0.70 - 1.20 mg/dl) - on (b)(6) 2019: 0.93 mg/dl.Blood heavy metal test (0.6 - 7.5 mcg/l) - on (b)(6) 2019: 4.65 mcg/l.Blood potassium (3.6 - 5.0 meq/l) - on (b)(6) 2019: 4.7 meq/l.Blood sodium (135.0 - 148.0 meq/l) - on (b)(6) 2019: 139.7 meq/l.Eosinophil percentage (1.0 - 5.0 %) - on (b)(6) 2019: 0.5 %.Gynaecological examination - on (b)(6) 2019: flabby abdomen, painful on palpation of the flank, absence of masses palpable.Pubic of conformation and gynecoid quantity.Trophic vulva, with large and small lips with normal dimensions without changes.Specular examination showed a neck with jec 0 without ulcers or polyps.Vaginal discharge with a characteristic and habitual appearance, color and odor.Vaginal touch, mobile uterus in retroversoflexion, with regular surface and normal dimensions.Haematocrit (37.0 - 44.0 %) - on (b)(6) 2020: 44.2 %.Human chorionic gonadotropin - on (b)(6) 2015: negative.Lymphocyte percentage (20.0 - 50.0 %) - on (b)(6) 2019: 17.4 %.Magnetic resonance imaging abdominal - on (b)(6) 2019: essure present; on (b)(6) 2020: essure present.Mean cell haemoglobin (27.0 - 32.0 pg) - on (b)(6) 2020: 26.8 pg.Neutrophil count - on (b)(6) 2019: 9.1.Neutrophil percentage (40.0 - 74.0 %) - on (b)(6) 2019: 76.2 %.Red blood cell count (3.90 - 5.30 10 thousand per microlitre) - on (b)(6) 2020: 5.41 10 thousand per microlitre.Red cell distribution width (12.0 - 17.0 %) - on (b)(6) 2019: 11.5 %; on (b)(6) 2020: 11.9 %.Ultrasound abdomen - on (b)(6) 2017: unremarkable.Ultrasound scan - on (b)(6) 2015: essure in the regions of the uterine horns, linear on the right and circular on the left embedded in the myometrium; on (b)(6) 2018: uterine 93 cc, endometrium 6mm, right ovarian 4.7 cc, left ovarian 11.1 cc; on (b)(6) 2020: essure in endometrium.White blood cell count (4.0 - 11.0 10*3/ul) - on (b)(6) 2019: 11.9 10*3/ul.X-ray - on (b)(6) 2019: presence of metallic device; on (b)(6) 2020: essure dislocated, in eminence of to perforate the internal organs.Essure fragmented in several parts.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.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 and batch record review could not be conducted, as no sample or batch number were available.Most recent follow-up information incorporated above includes: on 28-apr-2021: quality safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('essure dislocation'), embedded device ('essure in endometriun') and device breakage ('essure was found fragmented in many parts') in a 39-year-old female patient who had essure (batch no.B02267) inserted for contraception.The occurrence of additional non-serious events is detailed below.The patient's medical history included menarche (13 years-old) in 1994, gravida ii and parity 2.Previously administered products included for an unreported indication: microvilar.Concomitant products included drospirenone + ethinylestradiol-beta-cyclodextrin (yaz flex).On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2015, the patient experienced procedural pain ("pain in the lower abdomen"), pelvic pain ("pelvc pain, colic pain, stitches pain, pelvic pain since insertion"), fatigue ("fatigue") and headache ("headache").On (b)(6) 2015, the patient experienced embedded device (seriousness criterion medically significant).In 2017, the patient experienced migraine with aura ("migraine with aura"), nausea ("nausea"), pain in extremity ("lower limb pain"), polymenorrhagia ("increased flow and frequency of menstruation (hypermenorrhea)"), dysmenorrhoea ("severe pain during menstrual flow"), dyspareunia ("pain during intercourse"), vaginal discharge ("increased vaginal secretion with odor and pruritus"), vulvovaginal pruritus ("increased vaginal secretion with odor and pruritus"), recurrent uti ("recurrent uti"), diarrhoea ("sporadic intermittent diarrhea"), anxiety disorder ("anxiety disorder"), back pain ("lumbar pain") and vomiting ("vomiting").On (b)(6) 2019, the patient experienced haematuria ("haematuria") and dysuria ("dysuria").On (b)(6) 2019, the patient experienced urinary tract infection ("urinary tract infection") with dysuria, haematuria and pelvic pain.On 9-apr-2020, the patient experienced heavy menstrual bleeding ("considerable and intense increase in menstrual flow, reaching up to 15 (fifteen) days").On (b)(6) 2020, the patient experienced intermenstrual bleeding ("metrorrhagia").On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant) and device breakage (seriousness criterion medically significant).The patient was treated with analgesics and antiinflammatory agents.Essure treatment was ongoing at the time of the report.On (b)(6) 2015, the procedural pain had resolved.At the time of the report, the device dislocation, embedded device, recurrent uti, urinary tract infection and pelvic pain had not resolved and the device breakage, migraine with aura, nausea, pain in extremity, polymenorrhagia, dysmenorrhoea, dyspareunia, vaginal discharge, vulvovaginal pruritus, diarrhoea, anxiety disorder, back pain, fatigue, headache, vomiting, intermenstrual bleeding, haematuria, dysuria and heavy menstrual bleeding outcome was unknown.The reporter considered anxiety disorder, back pain, device breakage, device dislocation, diarrhoea, dysmenorrhoea, dyspareunia, dysuria, embedded device, fatigue, haematuria, headache, heavy menstrual bleeding, intermenstrual bleeding, migraine with aura, nausea, pain in extremity, pelvic pain, polymenorrhagia, procedural pain, recurrent uti, vaginal discharge, vomiting, vulvovaginal pruritus and urinary tract infection to be related to essure.The reporter commented: essure placement procedure was complicated, on left side endometrium obstruct the ostium, right side device was placed only on the 2nd trial.She complained of pelvic pain in outpatient clinics at (b)(6) 2020.Diagnostic results (normal ranges are provided in parenthesis if available): blood creatine (0.70 - 1.20 mg/dl) - on (b)(6) 2019: 0.93 mg/dl.Blood heavy metal test (0.6 - 7.5 mcg/l) - on (b)(6) 2019: 4.65 mcg/l.Blood potassium (3.6 - 5.0 meq/l) - on (b)(6) 2019: 4.7 meq/l.Blood sodium (135.0 - 148.0 meq/l) - on (b)(6) 2019: 139.7 meq/l.Eosinophil percentage (1.0 - 5.0 %) - on (b)(6) 2019: 0.5 %.Gynaecological examination - on (b)(6) 2019: flabby abdomen, painful on palpation of the flank, absence of masses palpable.Pubic of conformation and gynecoid quantity.Trophic vulva, with large and small lips with normal dimensions without changes.Specular examination showed a neck with jec 0 without ulcers or polyps.Vaginal discharge with a characteristic and habitual appearance, color and odor.Vaginal touch, mobile uterus in retroversoflexion, with regular surface and normal dimensions.Haematocrit (37.0 - 44.0 %) - on (b)(6) 2020: 44.2 %.Human chorionic gonadotropin - on (b)(6) 2015: negative.Lymphocyte percentage (20.0 - 50.0 %) - on (b)(6) 2019: 17.4 %.Magnetic resonance imaging abdominal - on (b)(6) 2019: essure present; on (b)(6) 2020: essure present.Mean cell haemoglobin (27.0 - 32.0 pg) - on (b)(6) 2020: 26.8 pg.Neutrophil count - on (b)(6) 2019: 9.1.Neutrophil percentage (40.0 - 74.0 %) - on (b)(6) 2019: 76.2 %.Red blood cell count (3.90 - 5.30 10 thousand per microlitre) - on (b)(6) 2020: 5.41 10 thousand per microlitre.Red cell distribution width (12.0 - 17.0 %) - on (b)(6) 2019: 11.5 %; on (b)(6) 2020: 11.9 %.Ultrasound abdomen - on (b)(6) 2017: unremarkable.Ultrasound scan - on (b)(6) 2015: essure in the regions of the uterine horns, linear on the right and circular on the left embedded in the myometrium; on (b)(6) 2018: uterine 93 cc, endometrium 6mm, right ovarian 4.7 cc, left ovarian 11.1 cc; on (b)(6) 2020: uterine 117.3 cc, endometrium 6mm, right ovarian 2.0 cc, left ovarian 15.2 cc.Essure in endometrium.White blood cell count (4.0 - 11.0 10*3/ul) - on (b)(6) 2019: 11.9 10*3/ul.X-ray - on (b)(6) 2019: presence of metallic device; on (b)(6) 2020: essure dislocated, in eminence of to perforate the internal organs.Essure fragmented in several parts.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.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 and batch record review could not be conducted, as no sample or batch number were available.Most recent follow-up information incorporated above includes: on 14-jun-2021: the follow information were updated mew lawyer's reporter, essure lot number, other concomitant product, vomiting, metrorrhagia, dysuria, haematuria, menstruation prolonged, onset date polymenorrhagia, vaginal itching, offensive vaginal discharge, recurrent uti, diarrhea, anxiety disorder; outcome for pelvic pain was updated to not resolved.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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