| 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
Pelvic Inflammatory Disease (2000); Perforation (2001); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
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| Event Date 01/01/2017 |
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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 dislocated (near to perfurate her internal organs)') and device breakage ('essure fragmentation') 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 parity 2 (2 gestations).Concomitant products included medroxyprogesterone acetate (demedrox) since 2016.In 2014, the patient had essure inserted.In 2014, the patient experienced abdominal pain lower ("pain like cramps in the lower abdomen") and procedural pain ("left hospital with lower abdominal pain").In 2017, the patient experienced headache ("cephalea"), pain in extremity ("pre-menstrual lower limbs pain"), back pain ("lumbar pain"), menorrhagia ("menstrual flow increased with clots"), polymenorrhoea ("menstrual frequency increased"), dysmenorrhoea ("intense pain during menstrual cycle"), dyspareunia ("intense pain during sexual intercourse"), depression ("depressive condition") with anxiety, pain nos ("pain like twinge"), breast pain ("mastalgia"), abdominal distension ("distention nos"), oedema ("edema nos"), hypoaesthesia ("numbness nos"), peripheral swelling ("legs swelling"), tremor ("tremors"), pelvic pain ("pelvic pain"), feeling abnormal ("sensation of uterine perforation"), fatigue ("fatigue"), loss of libido ("loss of libido"), coital bleeding ("bleeding during and after sexual intercourse"), uterine inflammation ("uterine inflammation"), arthralgia ("joint pain"), mood altered ("mood change"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("liquid in abdomen"), general body pain ("generalized pain") and vaginal discharge ("vaginal secretion with odor").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.At the time of the report, the device dislocation, device breakage, headache, pain in extremity, back pain, menorrhagia, polymenorrhoea, abdominal pain lower, dysmenorrhoea, dyspareunia, depression, pain nos, breast pain, abdominal distension, oedema, hypoaesthesia, peripheral swelling, tremor, pelvic pain, feeling abnormal, fatigue, loss of libido, coital bleeding, uterine inflammation, arthralgia, mood altered, alopecia, adenomyosis, intra-abdominal fluid collection, general body pain and vaginal discharge had not resolved and the procedural pain outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, arthralgia, back pain, breast pain, coital bleeding, depression, device breakage, device dislocation, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, headache, hypoaesthesia, intra-abdominal fluid collection, loss of libido, menorrhagia, mood altered, oedema, pain in extremity, pain nos, pelvic pain, peripheral swelling, polymenorrhoea, procedural pain, tremor, uterine inflammation, vaginal discharge and general body pain to be related to essure.The reporter commented: after the insertion of essure, consumer presented lower abdominal cramps and she was medicated with analgesics and antiinflammatory nos.She presented improvement after some days.In 2017, besides of the lower abdominal pain, she also started presenting pain during the menstrual cycle.Due to it, she went to the hospital sometimes (outpatient) and received antiinflammatory and analgesic drugs, with partial improvement.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: essure dislocated, in eminence of to perforate the internal organs.Essure fragmented in several parts.
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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 dislocated (near to perforate her internal organs)'), device breakage ('essure fragmentation') and uterine inflammation ('uterine inflammation') in a 40-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 parity 2 and gravida ii.Concomitant products included medroxyprogesterone acetate (demedrox) since 2016.In 2014, the patient had essure inserted.In 2014, the patient experienced abdominal pain lower ("pain like cramps in the lower abdomen") and procedural pain ("left hospital with lower abdominal pain").In 2017, the patient experienced uterine inflammation (seriousness criteria medically significant and intervention required), pelvic pain ("pelvic pain"), back pain ("lumbar pain"), headache ("cephalea"), dyspareunia ("intense pain during sexual intercourse"), pain in extremity ("pre-menstrual lower limbs pain"), menorrhagia ("menstrual flow increased with clots"), polymenorrhoea ("menstrual frequency increased"), dysmenorrhoea ("intense pain during menstrual cycle"), depression ("depressive condition") with anxiety, pain ("pain like twinge / generalized pain"), breast pain ("mastalgia"), abdominal distension ("distention nos"), oedema ("edema nos"), hypoaesthesia ("numbness nos"), peripheral swelling ("legs swelling"), tremor ("tremors"), feeling abnormal ("sensation of uterine perforation"), fatigue ("fatigue"), loss of libido ("loss of libido"), coital bleeding ("bleeding during and after sexual intercourse"), arthralgia ("joint pain"), mood altered ("mood change"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("liquid in abdomen") and vaginal discharge ("vaginal secretion with odor").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 not changed.At the time of the report, the device dislocation, device breakage, uterine inflammation, pelvic pain, abdominal pain lower, back pain, headache, dyspareunia, pain in extremity, menorrhagia, polymenorrhoea, dysmenorrhoea, depression, pain, breast pain, abdominal distension, oedema, hypoaesthesia, peripheral swelling, tremor, feeling abnormal, fatigue, loss of libido, coital bleeding, arthralgia, mood altered, alopecia, adenomyosis, intra-abdominal fluid collection and vaginal discharge had not resolved and the procedural pain outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, arthralgia, back pain, breast pain, coital bleeding, depression, device breakage, device dislocation, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, headache, hypoaesthesia, intra-abdominal fluid collection, loss of libido, menorrhagia, mood altered, oedema, pain, pain in extremity, pelvic pain, peripheral swelling, polymenorrhoea, procedural pain, tremor, uterine inflammation and vaginal discharge to be related to essure.The reporter commented: after the insertion of essure, consumer presented lower abdominal cramps and she was medicated with analgesics and antiinflammatory nos.She presented improvement after some days.In 2017, besides of the lower abdominal pain, she also started presenting pain during the menstrual cycle.Due to it, she went to the hospital sometimes (outpatient) and received antiinflammatory and analgesic drugs, with partial improvement.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: 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 6-aug-2020: quality-safety evaluation of ptc; after internal review, event uterine inflammation was upgraded to serious incident event; duplicated event pain was deleted.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 dislocated (near to perfurate her internal organs)'), device breakage ('essure fragmentation') and uterine inflammation ('uterine inflammation') in a 40-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 renal abscess in 2013, parity 2, gravida ii and depression.Previously administered products included for an unreported indication: demedrox.Concomitant products included medroxyprogesterone acetate (demedrox) since 2016.In (b)(6) 2014, the patient had essure inserted.In 2014, the patient experienced abdominal pain lower ("pain like cramps in the lower abdomen") and procedural pain ("left hospital with lower abdominal pain").In 2017, the patient experienced uterine inflammation (seriousness criteria medically significant and intervention required), pelvic pain ("pelvic pain"), back pain ("lumbar pain"), headache ("cephalea"), dyspareunia ("intense pain during sexual intercourse"), pain in extremity ("pre-menstrual lower limbs pain"), menorrhagia ("menstrual flow increased with clots"), polymenorrhoea ("menstrual frequency increased"), dysmenorrhoea ("intense pain during menstrual cycle"), depression ("depressive condition") with anxiety, pain ("pain like twinge / generalized pain"), breast pain ("mastalgia"), abdominal distension ("distention nos"), oedema ("edema nos"), hypoaesthesia ("numbness nos"), peripheral swelling ("legs swelling"), tremor ("tremors"), feeling abnormal ("sensation of uterine perforation"), fatigue ("fatigue"), loss of libido ("loss of libido"), coital bleeding ("bleeding during and after sexual intercourse"), arthralgia ("joint pain"), mood altered ("mood change"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("liquid in abdomen") and vaginal discharge ("vaginal secretion with odor").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 not changed.At the time of the report, the device dislocation, device breakage, uterine inflammation, pelvic pain, abdominal pain lower, back pain, headache, dyspareunia, pain in extremity, menorrhagia, polymenorrhoea, dysmenorrhoea, depression, pain, breast pain, abdominal distension, oedema, hypoaesthesia, peripheral swelling, tremor, feeling abnormal, fatigue, loss of libido, coital bleeding, arthralgia, mood altered, alopecia, adenomyosis, intra-abdominal fluid collection and vaginal discharge had not resolved and the procedural pain outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, arthralgia, back pain, breast pain, coital bleeding, depression, device breakage, device dislocation, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, headache, hypoaesthesia, intra-abdominal fluid collection, loss of libido, menorrhagia, mood altered, oedema, pain, pain in extremity, pelvic pain, peripheral swelling, polymenorrhoea, procedural pain, tremor, uterine inflammation and vaginal discharge to be related to essure.No further causality assessment were provided for the product.The reporter commented: after the insertion of essure, consumer presented lower abdominal cramps and she was medicated with analgesics and antiinflamatory nos.She presented improvement after some days.In 2017, besides of the lower abdominal pain, she also started presenting pain during the menstrual cycle.Due to it, she went to the hospital sometimes (outpatient) and received antiinflamatory and analgesic drugs, with partial improvement.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: essure dislocated, in eminence of to perforate the internal organs.Essure fragmented in several parts.; on (b)(6) 2020: essure in correct location in fallopian tubes.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 dislocated (near to perforate her internal organs)'), device breakage ('essure fragmentation') and uterine inflammation ('uterine inflammation').In a 40-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: renal abscess in 2013, parity 2, gravida ii and depression.Previously administered products, included for an unreported indication: demedrox.Concomitant products included: medroxyprogesterone acetate (demedrox) since 2016.On (b)(6) 2014, the patient had essure inserted.On 2014, the patient experienced abdominal pain lower ("pain like cramps in the lower abdomen") and procedural pain ("left hospital with lower abdominal pain").On 2017, the patient experienced uterine inflammation (seriousness criteria medically significant and intervention required), pelvic pain ("pelvic pain"), back pain ("lumbar pain"), headache ("cephalea"), dyspareunia ("intense pain during sexual intercourse"), pain in extremity ("pre-menstrual lower limbs pain"), menorrhagia ("menstrual flow increased with clots"), polymenorrhoea ("menstrual frequency increased"), dysmenorrhoea ("intense pain during menstrual cycle"), depression ("depressive condition") with anxiety, pain ("pain like twinge/generalized pain"), breast pain ("mastalgia"), abdominal distension ("distention nos"), oedema ("edema nos"), hypoaesthesia ("numbness nos"), peripheral swelling ("legs swelling"), tremor ("tremors"), feeling abnormal ("sensation of uterine perforation"), fatigue ("fatigue"), loss of libido ("loss of libido"), coital bleeding ("bleeding during and after sexual intercourse"), arthralgia ("joint pain"), mood altered ("mood change"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("liquid in abdomen") and vaginal discharge ("vaginal secretion with odor").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 not changed.At the time of the report, the device dislocation, device breakage, uterine inflammation, pelvic pain, abdominal pain lower, back pain, headache, dyspareunia, pain in extremity, menorrhagia, polymenorrhoea, dysmenorrhoea, depression, pain, breast pain, abdominal distension, oedema, hypoaesthesia, peripheral swelling, tremor, feeling abnormal, fatigue, loss of libido, coital bleeding, arthralgia, mood altered, alopecia, adenomyosis, intra-abdominal fluid collection and vaginal discharge had not resolved.And the procedural pain outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, arthralgia, back pain, breast pain, coital bleeding, depression, device breakage, device dislocation, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, headache, hypoaesthesia, intra-abdominal fluid collection, loss of libido, menorrhagia, mood altered, oedema, pain, pain in extremity, pelvic pain, peripheral swelling, polymenorrhoea, procedural pain, tremor, uterine inflammation and vaginal discharge to be related to essure.The reporter commented: after the insertion of essure, consumer presented lower abdominal cramps.And she was medicated with analgesics and antiinflammatory nos.She presented improvement after some days.On 2017, besides of the lower abdominal pain, she also started, presenting pain, during the menstrual cycle.Due to it, she went to the hospital sometimes (outpatient) and received antiinflammatory and analgesic drugs, with partial improvement.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray: on an unknown date, essure dislocated in eminence of to perforate the internal organs.Essure fragmented in several parts.On (b)(6) 2020: essure in correct location in fallopian tubes.Quality safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2021, reporter's initials, essure insertion date were updated, lab test and relevant history were added.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 dislocated (near to perforate her internal organs)'), device breakage ('essure fragmentation') and uterine inflammation ('uterine inflammation') in a 40-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 renal abscess (with forty days of hospitalization.) in 2013, parity 2, gravida ii, depression, migraine and menarche (she was 12 years old).Smoker; denies: diabetes mellitus, hypertension, epilepsy, heart disease, thyroid disease, glaucoma, asthma bronchial, anemias, surgical interventions.Previously administered products included for an unreported indication: demedrox.Concurrent conditions included drug intolerance (intolerance to selective serotonin reuptake inhibitors).Family history included depressive disorder (her father and her mother; 2017 her father attempted suicide by taking pesticide.).Concomitant products included medroxyprogesterone acetate (demedrox) since 2016.In (b)(6) 2014, the patient had essure inserted.In 2014, the patient experienced abdominal pain lower ("pain like cramps in the lower abdomen") and procedural pain ("left hospital with lower abdominal pain").In 2017, the patient experienced uterine inflammation (seriousness criteria medically significant and intervention required), pelvic pain ("pelvic pain"), back pain ("lumbar pain"), headache ("cephala"), dyspareunia ("intense pain during sexual intercourse"), pain in extremity ("pre-menstrual lower limbs pain"), heavy menstrual bleeding ("menstrual flow increased with clots"), polymenorrhoea ("menstrual frequency increased"), dysmenorrhoea ("intense pain during menstrual cycle"), depression ("depressive condition / sadness / mild depressive episode") with anxiety, general body pain ("pain like twinge / generalized pain"), breast pain ("mastalgia"), abdominal distension ("distention nos"), oedema ("edema nos"), hypoaesthesia ("numbness nos"), peripheral swelling ("legs swelling"), tremor ("tremors"), feeling abnormal ("sensation of uterine perforation"), fatigue ("fatigue"), loss of libido ("loss of libido"), coital bleeding ("bleeding during and after sexual intercourse"), arthralgia ("joint pain"), mood altered ("mood change"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("liquid in abdomen") and vaginal discharge ("vaginal secretion with odor").In 2019, the patient experienced amenorrhoea ("amenorrhea").On (b)(6) 2020, the patient experienced varicose vein ("superficial varicose veins of the lower limbs") and palpitations ("palpitation in heart (several times a day)").On (b)(6) 2020, the patient experienced pain upon movement ("pain when walking").On (b)(6) 2020, the patient experienced dry mouth ("mild xerostomia").On (b)(6) 2020, the patient experienced dizziness ("dizziness").On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), device breakage (seriousness criterion medically significant) and myalgia ("muscle pain").The patient was treated with analgesics, antiinflammatory agents, desvenlafaxine (desvenlafaxina), escitalopram oxalate (exodus), nortriptyline (nortriptilina) and nortriptyline hydrochloride (pamelor).Essure treatment was not changed.At the time of the report, the device dislocation, device breakage, uterine inflammation, pelvic pain, abdominal pain lower, back pain, headache, dyspareunia, heavy menstrual bleeding, polymenorrhoea, dysmenorrhoea, depression, breast pain, abdominal distension, oedema, hypoaesthesia, peripheral swelling, tremor, feeling abnormal, fatigue, loss of libido, coital bleeding, arthralgia, alopecia, adenomyosis, intra-abdominal fluid collection and vaginal discharge had not resolved, the pain in extremity, general body pain and mood altered was resolving and the procedural pain, dizziness, dry mouth, pain upon movement, varicose vein, palpitations and amenorrhoea outcome was unknown.The reporter considered dizziness and dry mouth to be unrelated to essure.The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, amenorrhoea, arthralgia, back pain, breast pain, coital bleeding, depression, device breakage, device dislocation, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, general body pain, headache, heavy menstrual bleeding, hypoaesthesia, intra-abdominal fluid collection, loss of libido, mood altered, myalgia, oedema, pain in extremity, palpitations, pelvic pain, peripheral swelling, polymenorrhoea, procedural pain, tremor, uterine inflammation, vaginal discharge, varicose vein and pain upon movement to be related to essure.The reporter commented: after the insertion of essure, consumer presented lower abdominal cramps and she was medicated with analgesics and antiinflammatory nos.She presented improvement after some days.In 2017, besides of the lower abdominal pain, she also started presenting pain during the menstrual cycle.Due to it, she went to the hospital sometimes (outpatient) and received antiinflammatory and analgesic drugs, with partial improvement.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram abdomen - on (b)(6) 2013: right kidney with enlarged dimensions.Physical examination - on (b)(6) 2019: uterus in anteversoflexion, with regular surface and normal dimensions.Ultrasound abdomen - on (b)(6) 2019: normal.Ultrasound scan vagina - on (b)(6) 2019: uterus: 45.8 cc; endometrium: 4 mm; right ovary: 4.2 cc and left ovary: 9.0 cc.X-ray - on an unknown date: essure dislocated, in eminence of to perforate the internal organs.Essure fragmented in several parts.; on (b)(6) 2020: essure in correct location in fallopian tubes.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 21-may-2021: new adverse events: myalgia, palpitation in heart (several times a day), varicose veins, amenorrhea, dizziness, xerostomia.The outcome of the adverse events "pain', 'lower limbs pain' and mood changed were updated to recovering/resolving; family history, medical history, lab data added, concurrent conditions (intolerance to selective serotonin reuptake inhibitors) and drug to treat the adverse events.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 dislocated (near to perfurate her internal organs)'), device breakage ('essure fragmentation') and uterine inflammation ('uterine inflammation') in a 40-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 renal abscess (with forty days of hospitalization.) in 2013, parity 2, gravida ii, depression, migraine and menarche (she was 12 years old).Smoker; denies: diabetes mellitus, hypertension, epilepsy, heart disease, thyroid disease, glaucoma, asthma bronchial, anemias, surgical interventions.Previously administered products included for an unreported indication: demedrox.Concurrent conditions included drug intolerance (intolerance to selective serotonin reuptake inhibitors).Family history included depressive disorder (her father and her mother; 2017 her father attempted suicide by taking pesticide.).Concomitant products included medroxyprogesterone acetate (demedrox) since 2016.In (b)(6) 2014, the patient had essure inserted.In 2014, the patient experienced abdominal pain lower ("pain like cramps in the lower abdomen") and procedural pain ("left hospital with lower abdominal pain").In 2017, the patient experienced uterine inflammation (seriousness criteria medically significant and intervention required), pelvic pain ("pelvic pain"), back pain ("lumbar pain"), headache ("cephalea"), dyspareunia ("intense pain during sexual intercourse"), pain in extremity ("pre-menstrual lower limbs pain"), heavy menstrual bleeding ("menstrual flow increased with clots"), polymenorrhoea ("menstrual frequency increased"), dysmenorrhoea ("intense pain during menstrual cycle"), depression ("depressive condition / sadness / mild depressive episode") with anxiety, general body pain ("pain like twinge / generalized pain"), breast pain ("mastalgia"), abdominal distension ("distention nos"), oedema ("edema nos"), hypoaesthesia ("numbness nos"), peripheral swelling ("legs swelling"), tremor ("tremors"), feeling abnormal ("sensation of uterine perforation"), fatigue ("fatigue"), loss of libido ("loss of libido"), coital bleeding ("bleeding during and after sexual intercourse"), arthralgia ("joint pain"), mood altered ("mood change"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("liquid in abdomen") and vaginal discharge ("vaginal secretion with odor").In 2019, the patient experienced amenorrhoea ("amenorrhea").On (b)(6) 2020, the patient experienced varicose vein ("superficial varicose veins of the lower limbs") and palpitations ("palpitation in heart (several times a day)").On (b)(6) 2020, the patient experienced pain upon movement ("pain when walking").On (b)(6) 2020, the patient experienced dry mouth ("mild xerostomia").On (b)(6) 2020, the patient experienced dizziness ("dizziness").On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), device breakage (seriousness criterion medically significant) and myalgia ("muscle pain").The patient was treated with analgesics, antiinflammatory agents, desvenlafaxine (desvenlafaxina), escitalopram oxalate (exodus), nortriptyline (nortriptilina) and nortriptyline hydrochloride (pamelor).Essure treatment was not changed.At the time of the report, the device dislocation, device breakage, uterine inflammation, pelvic pain, abdominal pain lower, back pain, headache, dyspareunia, heavy menstrual bleeding, polymenorrhoea, dysmenorrhoea, depression, breast pain, abdominal distension, oedema, hypoaesthesia, peripheral swelling, tremor, feeling abnormal, fatigue, loss of libido, coital bleeding, arthralgia, alopecia, adenomyosis, intra-abdominal fluid collection and vaginal discharge had not resolved, the pain in extremity, general body pain and mood altered was resolving and the procedural pain, dizziness, dry mouth, pain upon movement, varicose vein, palpitations and amenorrhoea outcome was unknown.The reporter considered dizziness and dry mouth to be unrelated to essure.The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, amenorrhoea, arthralgia, back pain, breast pain, coital bleeding, depression, device breakage, device dislocation, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, general body pain, headache, heavy menstrual bleeding, hypoaesthesia, intra-abdominal fluid collection, loss of libido, mood altered, myalgia, oedema, pain in extremity, palpitations, pelvic pain, peripheral swelling, polymenorrhoea, procedural pain, tremor, uterine inflammation, vaginal discharge, varicose vein and pain upon movement to be related to essure.No further causality assessment were provided for the product.The reporter commented: after the insertion of essure, consumer presented lower abdominal cramps and she was medicated with analgesics and antiinflamatory nos.She presented improvement after some days.In 2017, besides of the lower abdominal pain, she also started presenting pain during the menstrual cycle.Due to it, she went to the hospital sometimes (outpatient) and received antiinflamatory and analgesic drugs, with partial improvement.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram abdomen - on (b)(6) 2013: right kidney with enlarged dimensions.Physical examination - on (b)(6) 2019: uterus in anteversoflexion, with regular surface and normal dimensions.Ultrasound abdomen - on (b)(6) 2019: normal.Ultrasound scan vagina - on (b)(6) 2019: uterus: 45.8 cc; endometrium: 4 mm; right ovary: 4.2 cc and left ovary: 9.0 cc.X-ray - on an unknown date: essure dislocated, in eminence of to perforate the internal organs.Essure fragmented in several parts.; on (b)(6) 2020: essure in correct location in fallopian tubes.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 7-jun-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 consumer and subsequently by a lawyer and describes the occurrence of device dislocation ('essure dislocated (near to perfurate her internal organs)'), device breakage ('essure fragmentation') and uterine inflammation ('uterine inflammation') in a 34-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 renal abscess (with forty days of hospitalization.) in 2013, renal abscess (showed on ct scan) on (b)(6) 2013, cholestasis on (b)(6) 2013, pyelonephritis (left side with perirenal abscess) on (b)(6) 2013, abdominal distension (inpatient during 40 days) on (b)(6) 2013, pneumonia on (b)(6) 2013, pyelonephritis on (b)(6) 2013, arthromyalgia on (b)(6) 2013, parity 2 (vaginal delivery), gravida ii, migraine and menarche (she was 12 years old).Smoker; denies: diabetes mellitus, hypertension, epilepsy, heart disease, thyroid disease, glaucoma, asthma bronchial, anemias, surgical interventions.Previously administered products included for anxiety disturbance: fluoxetina and amitriptilina; for depression: fluoxetina and amitriptilina; for an unreported indication: intrauterine until (b)(6) 2014, tienam from (b)(6) 2013, norfloxacina on (b)(6) 2013, cefepima from (b)(6) 2013, levofloxacino, injectable contraceptive and demedrox.Concurrent conditions included abdominal pain (inpatient during 40 days) since (b)(6) 2013, depression since 2008, smoker (use to smoke 20 cigarettes per day, at time of this report 10 cigarettes per day) since 1995, drug intolerance (intolerance to selective serotonin reuptake inhibitors) and anxiety disorder.The patient also had a family history of depressive disorder (her father and her mother; 2017 her father attempted suicide by taking pesticide.), hypertension, acute myocardial infarction, depression, alcohol addiction and depression.Concomitant products included medroxyprogesterone (medroxiprogesterona) since 2018 for contraception as well as estradiol valerate + levonorgestrel (cicloprimogyna) and medroxyprogesterone acetate (demedrox) since 2016.On (b)(6) 2014, the patient had essure inserted.In 2014, the patient experienced abdominal pain lower ("pain like cramps in the lower abdomen / abdominal pain") and procedural pain ("left hospital with lower abdominal pain").On (b)(6) 2014, the patient experienced urticaria ("urticaria"), 2 months 7 days after insertion of essure.In 2017, the patient experienced uterine inflammation (seriousness criterion medically significant), pelvic pain ("pelvic pain"), back pain ("lumbar pain"), headache ("cephalea"), dyspareunia ("intense pain during sexual intercourse"), pain in extremity ("pre-menstrual lower limbs pain / leg pain with purple spots"), heavy menstrual bleeding ("menstrual flow increased with clots"), polymenorrhoea ("menstrual frequency increased"), dysmenorrhoea ("intense pain during menstrual cycle"), depression ("depressive condition / sadness / mild depressive episode") with anxiety, the first episode of pain ("pain like twinge / generalized pain"), breast pain ("mastalgia"), abdominal distension ("distention nos"), oedema ("edema nos"), hypoaesthesia ("numbness nos"), peripheral swelling ("legs swelling"), tremor ("tremors"), feeling abnormal ("sensation of uterine perforation"), fatigue ("fatigue"), loss of libido ("loss of libido"), coital bleeding ("bleeding during and after sexual intercourse"), arthralgia ("joint pain"), mood altered ("mood change"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("liquid in abdomen") and vaginal discharge ("vaginal secretion with odor").In 2019, the patient experienced amenorrhoea ("amenorrhea during intake medroxiprogesterona").On (b)(6) 2020, the patient experienced varicose vein ("superficial varicose veins of the lower limbs") and palpitations ("palpitation in heart (several times a day)").On (b)(6) 2020, the patient experienced the second episode of pain ("pain when walking / general body pain").On (b)(6) 2020, the patient experienced dry mouth ("mild xerostomia").On (b)(6) 2020, the patient experienced dizziness ("dizziness").On (b)(6) 2021, the patient experienced somnolence ("drowsy on daytime").On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), device breakage (seriousness criterion medically significant), myalgia ("muscle pain"), nausea ("nausea"), abdominal pain ("abdominal pain"), flank pain ("left flank pain") and adjustment disorder with mixed anxiety and depressed mood ("very anxiety, feeling of butterfly belly, increase heart beats multiple times per day") with depressed mood and crying.The patient was treated with amitriptyline (amitriptilina), analgesics, antiinflammatory agents, desvenlafaxine (desvenlafaxina), dexchlorpheniramine maleate (polaramine), duloxetine hydrochloride (velija), escitalopram oxalate (exodus), fluoxetine (fluoxetina), mirtazapine (razapina), nortriptyline (nortriptilina), nortriptyline hydrochloride (pamelor), paroxetine (paroxetina), pregabalin (pregabalina), promethazine (prometazina), trazodone hydrochloride (donaren) and venlafaxine hydrochloride (alenthus).Essure treatment was not changed.At the time of the report, the device dislocation, device breakage, uterine inflammation, pelvic pain, abdominal pain lower, back pain, headache, dyspareunia, heavy menstrual bleeding, polymenorrhoea, dysmenorrhoea, depression, breast pain, abdominal distension, oedema, hypoaesthesia, peripheral swelling, tremor, feeling abnormal, fatigue, loss of libido, coital bleeding, arthralgia, alopecia, adenomyosis, intra-abdominal fluid collection and vaginal discharge had not resolved, the pain in extremity and mood altered was resolving and the procedural pain, dizziness, dry mouth, the last episode of pain, varicose vein, palpitations, amenorrhoea, urticaria, nausea, abdominal pain, flank pain, adjustment disorder with mixed anxiety and depressed mood and somnolence outcome was unknown.The reporter considered dizziness and dry mouth to be unrelated to essure.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, adenomyosis, adjustment disorder with mixed anxiety and depressed mood, alopecia, amenorrhoea, arthralgia, back pain, breast pain, coital bleeding, depression, device breakage, device dislocation, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, flank pain, headache, heavy menstrual bleeding, hypoaesthesia, intra-abdominal fluid collection, loss of libido, mood altered, myalgia, nausea, oedema, pain in extremity, palpitations, pelvic pain, peripheral swelling, polymenorrhoea, procedural pain, somnolence, tremor, urticaria, uterine inflammation, vaginal discharge, varicose vein, the first episode of pain and the second episode of pain to be related to essure.The reporter commented: essure placed without complication.After the insertion of essure, consumer presented lower abdominal cramps and she was medicated with analgesics and antiinflamatory nos.She presented improvement after some days.In 2017, besides of the lower abdominal pain, she also started presenting pain during the menstrual cycle.Due to it, she went to the hospital sometimes (outpatient) and received antiinflamatory and analgesic drugs, with partial improvement.Diagnostic results (normal ranges are provided in parenthesis if available): aspartate aminotransferase - on (b)(6) 2021: 17.Blood creatinine - on (b)(6) 2021: 0.98.Blood glucose - on (b)(6) 2021: 83.Blood potassium - on (b)(6) 2021: 5.45.Blood pressure measurement - on (b)(6) 2019: 100x60 mmhg.Blood prolactin - on (b)(6) 2019: 4.87.Blood sodium - on (b)(6) 2021: 140.Blood thyroid stimulating hormone - on (b)(6) 2019: 0.53.Blood uric acid - on (b)(6) 2021: 3.5.Body height (cm) - on (b)(6) 2019: 158 cm.Body mass index - on (b)(6) 2019: 20.4.Chest x-ray - on (b)(6) 2021: normal.Computerised tomogram abdomen - on (b)(6) 2013: right kidney with enlarged dimensions.Electrocardiogram - on (b)(6) 2021: normal.Gynaecological examination - on (b)(6) 2019: stained and hydrated mucous membranes, flaccid, painless abdomen, absence of palpable masses, conformational pubic hair and gynecoid quantity.Trophic vulva, with large and small lips of normal dimensions without alterations.Specular examination showed a cervix with jec 0 without ulcers or polyps.Vaginal secretion with a menstrual appearance with a characteristic and usual odor.Vaginal touch, anteversoflexion uterus, with regular surface and normal dimensions.Attachments without changes.; on (b)(6) 2019: uterus in anteversoflexion, with regular surface and normal dimensions.; on (b)(6) 2020: supra cervical and infraclavicular breasts, axillary without alterations on palpation.Painless normotensive abdomen without visceromegaly.Specular examination without macroscopic ectocervix changes.Lumbosacral spine palpation with pain in sciatica topography and we observed marked lordosis.Haematocrit (%) - on (b)(6) 2019: 50.5 %.Haemoglobin (g/dl) - on (b)(6) 2019: 15.4 g/dl; on (b)(6) 2021: 15.2 g/dl.International normalised ratio - on (b)(6) 2021: 1.01.Neutrophil count - on (b)(6) 2021: elevated.Platelet count (10*3/ul) - on (b)(6) 2019: 231 10*3/ul; on (b)(6) 2021: 224 10*3/ul.Prothrombin time - on (b)(6) 2021: 12.4.Red blood cell count (10 thousand cells per microlitre) - on (b)(6) 2019: 5.49 10 thousand cells per microlitre.Thyroxine free - on (b)(6) 2019: 0.46; on (b)(6) 2019: 1.05.Ultrasound abdomen - on (b)(6) 2019: normal; on (b)(6) 2020: essure well positioned; on (b)(6) 2020: the devices are positioned to the side.Ultrasound scan vagina - on (b)(6) 2019: uterus: 45.8 cc; endometrium: 4 mm; right ovary: 4.2 cc and left ovary: 9.0 cc with follicle 16mm; on (b)(6) 2020: essure well positioned; on (b)(6) 2020: uterus: 68 cc; endometrium: 3.6 mm; right ovary: 1.4 cc and left ovary: 4.0.Essure well positioned.Urinary sediment - on (b)(6) 2019: hg++.Hc 8p/c; on (b)(6) 2021: normal.Weight (kg) - on (b)(6) 2019: 51 kg.White blood cell count - on (b)(6) 2021: 14600.X-ray - on an unknown date: essure dislocated, in eminence of to perforate the internal organs.Essure fragmented in several parts.; on (b)(6) 2020: essure in correct location in fallopian tubes.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 1-feb-2022: the follow information were include medical history, historical drug, lab data, other treatment products, concomitant product, new events urticaria, nausea, abdominal pain, flank pain, adjustment disorder with mixed anxiety and depressed mood, somnolence 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 consumer and subsequently by a lawyer and describes the occurrence of device dislocation ('essure dislocated (near to perforate her internal organs)'), device breakage ('essure fragmentation') and uterine inflammation ('uterine inflammation') in a 34-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 renal abscess (with forty days of hospitalization.) in 2013, renal abscess (showed on ct scan) on (b)(6) 2013, cholestasis on (b)(6) 2013, pyelonephritis (left side with perirenal abscess) on (b)(6) 2013, abdominal distension (inpatient during 40 days) on (b)(6) 2013, pneumonia on (b)(6) 2013, pyelonephritis on (b)(6) 2013, arthromyalgia on (b)(6) 2013, parity 2 (vaginal delivery), gravida ii, migraine and menarche (she was 12 years old).Smoker; denies: diabetes mellitus, hypertension, epilepsy, heart disease, thyroid disease, glaucoma, asthma bronchial, anemias, surgical interventions.Previously administered products included for anxiety disturbance: fluoxetina and amitriptilina; for depression: fluoxetina and amitriptilina; for an unreported indication: intrauterine until (b)(6) 2014, tienam from (b)(6) 2013 to (b)(6) 2013, norfloxacina on (b)(6) 2013, cefepima from (b)(6) 2013 to (b)(6) 2013, levofloxacino, injectable contraceptive and demedrox.Concurrent conditions included abdominal pain (inpatient during 40 days) since (b)(6) 2013, depression since 2008, smoker (use to smoke 20 cigarettes per day, at time of this report 10 cigarettes per day) since 1995, drug intolerance (intolerance to selective serotonin reuptake inhibitors) and anxiety disorder.The patient also had a family history of depressive disorder (her father and her mother; 2017 her father attempted suicide by taking pesticide.), hypertension, acute myocardial infarction, familial risk factor, alcohol addiction and depression.Concomitant products included medroxyprogesterone (medroxiprogesterona) since 2018 for contraception as well as estradiol valerate + levonorgestrel (cicloprimogyna) and medroxyprogesterone acetate (demedrox) since 2016.On (b)(6) 2014, the patient had essure inserted.In 2014, the patient experienced abdominal pain lower ("pain like cramps in the lower abdomen / abdominal pain") and procedural pain ("left hospital with lower abdominal pain").On (b)(6) 2014, the patient experienced urticaria ("urticaria"), 2 months 7 days after insertion of essure.In 2017, the patient experienced uterine inflammation (seriousness criterion medically significant), pelvic pain ("pelvic pain"), back pain ("lumbar pain"), headache ("cephalea"), dyspareunia ("intense pain during sexual intercourse"), pain in extremity ("pre-menstrual lower limbs pain / leg pain with purple spots"), heavy menstrual bleeding ("menstrual flow increased with clots"), polymenorrhoea ("menstrual frequency increased"), dysmenorrhoea ("intense pain during menstrual cycle"), depression ("depressive condition / sadness / mild depressive episode") with anxiety, the first episode of pain ("pain like twinge / generalized pain"), breast pain ("mastalgia"), abdominal distension ("distention nos"), oedema ("edema nos"), hypoaesthesia ("numbness nos"), peripheral swelling ("legs swelling"), tremor ("tremors"), feeling abnormal ("sensation of uterine perforation"), fatigue ("fatigue"), loss of libido ("loss of libido"), coital bleeding ("bleeding during and after sexual intercourse"), arthralgia ("joint pain"), mood altered ("mood change"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("liquid in abdomen") and vaginal discharge ("vaginal secretion with odor").In 2019, the patient experienced amenorrhoea ("amenorrhea during intake medroxiprogesterona").On (b)(6)2020, the patient experienced varicose vein ("superficial varicose veins of the lower limbs") and palpitations ("palpitation in heart (several times a day)").On (b)(6) 2020, the patient experienced the second episode of pain ("pain when walking / general body pain").On (b)(6) 2020, the patient experienced dry mouth ("mild xerostomia").On (b)(6) 2020, the patient experienced dizziness ("dizziness").On (b)(6) 2021, the patient experienced somnolence ("drowsy on daytime").On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), device breakage (seriousness criterion medically significant), myalgia ("muscle pain"), nausea ("nausea"), abdominal pain ("abdominal pain"), flank pain ("left flank pain") and adjustment disorder with mixed anxiety and depressed mood ("very anxiety, feeling of butterfly belly, increase heart beats multiple times per day") with depressed mood and crying.The patient was treated with amitriptyline (amitriptilina), analgesics, antiinflammatory agents, desvenlafaxine (desvenlafaxina), dexchlorpheniramine maleate (polaramine), duloxetine hydrochloride (velija), escitalopram oxalate (exodus), fluoxetine (fluoxetina), mirtazapine (razapina), nortriptyline (nortriptilina), nortriptyline hydrochloride (pamelor), paroxetine (paroxetina), pregabalin (pregabalina), promethazine (prometazina), trazodone hydrochloride (donaren) and venlafaxine hydrochloride (alenthus).Essure treatment was not changed.At the time of the report, the device dislocation, device breakage, uterine inflammation, pelvic pain, abdominal pain lower, back pain, headache, dyspareunia, heavy menstrual bleeding, polymenorrhoea, dysmenorrhoea, depression, breast pain, abdominal distension, oedema, hypoaesthesia, peripheral swelling, tremor, feeling abnormal, fatigue, loss of libido, coital bleeding, arthralgia, alopecia, adenomyosis, intra-abdominal fluid collection and vaginal discharge had not resolved, the pain in extremity and mood altered was resolving and the procedural pain, dizziness, dry mouth, the last episode of pain, varicose vein, palpitations, amenorrhoea, urticaria, nausea, abdominal pain, flank pain, adjustment disorder with mixed anxiety and depressed mood and somnolence outcome was unknown.The reporter considered dizziness and dry mouth to be unrelated to essure.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, adenomyosis, adjustment disorder with mixed anxiety and depressed mood, alopecia, amenorrhoea, arthralgia, back pain, breast pain, coital bleeding, depression, device breakage, device dislocation, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, flank pain, headache, heavy menstrual bleeding, hypoaesthesia, intra-abdominal fluid collection, loss of libido, mood altered, myalgia, nausea, oedema, pain in extremity, palpitations, pelvic pain, peripheral swelling, polymenorrhoea, procedural pain, somnolence, tremor, urticaria, uterine inflammation, vaginal discharge, varicose vein, the first episode of pain and the second episode of pain to be related to essure.The reporter commented: essure placed without complication.After the insertion of essure, consumer presented lower abdominal cramps and she was medicated with analgesics and antiinflamatory nos.She presented improvement after some days.In 2017, besides of the lower abdominal pain, she also started presenting pain during the menstrual cycle.Due to it, she went to the hospital sometimes (outpatient) and received antiinflamatory and analgesic drugs, with partial improvement.Diagnostic results (normal ranges are provided in parenthesis if available): aspartate aminotransferase - on (b)(6) 2021: 17.Blood creatinine - on (b)(6) 2021: 0.98.Blood glucose - on (b)(6) 2021: 83.Blood potassium - on (b)(6) 2021: 5.45.Blood pressure measurement - on (b)(6) 2019: 100x60 mmhg.Blood prolactin - on (b)(6) 2019: 4.87.Blood sodium - on (b)(6) 2021: 140.Blood thyroid stimulating hormone - on (b)(6) 2019: 0.53.Blood uric acid - on (b)(6) 2021: 3.5.Body height (cm) - on (b)(6) 2019: 158 cm.Body mass index - on(b)(6) 2019: 20.4.Chest x-ray - on (b)(6) 2021: normal.Computerised tomogram abdomen - on (b)(6) 2013: right kidney with enlarged dimensions.Electrocardiogram - on (b)(6) 2021: normal.Gynaecological examination - on (b)(6) 2019: stained and hydrated mucous membranes, flaccid, painless abdomen, absence of palpable masses, conformational pubic hair and gynecoid quantity.Trophic vulva, with large and small lips of normal dimensions without alterations.Specular examination showed a cervix with jec 0 without ulcers or polyps.Vaginal secretion with a menstrual appearance with a characteristic and usual odor.Vaginal touch, anteversoflexion uterus, with regular surface and normal dimensions.Attachments without changes.; on (b)(6) 2019: uterus in anteversoflexion, with regular surface and normal dimensions.; on (b)(6) 2020: supra cervical and infraclavicular breasts, axillary without alterations on palpation.Painless normotensive abdomen without visceromegaly.Specular examination without macroscopic ectocervix changes.Lumbosacral spine palpation with pain in sciatica topography and we observed marked lordosis.Haematocrit (%) - on (b)(6) 2019: 50.5 %.Haemoglobin (g/dl) - on (b)(6) 2019: 15.4 g/dl; on (b)(6) 2021: 15.2 g/dl.International normalised ratio - on (b)(6) 2021: 1.01.Neutrophil count - on (b)(6) 2021: elevated.Platelet count (10*3/ul) - on (b)(6) 2019: 231 10*3/ul; on (b)(6) 2021: 224 10*3/ul.Prothrombin time - on (b)(6) 2021: 12.4.Red blood cell count (10 thousand cells per microlitre) - on (b)(6) 2019: 5.49 10 thousand cells per microlitre.Thyroxine free - on (b)(6) 2019: 0.46; on (b)(6) 2019: 1.05.Ultrasound abdomen - on (b)(6) 2019: normal; on (b)(6) 2020: essure well positioned; on (b)(6) 2020: the devices are positioned to the side.Ultrasound scan vagina - on (b)(6) 2019: uterus: 45.8 cc; endometrium: 4 mm; right ovary: 4.2 cc and left ovary: 9.0 cc with follicle 16mm; on (b)(6) 2020: essure well positioned; on (b)(6) 2020: uterus: 68 cc; endometrium: 3.6 mm; right ovary: 1.4 cc and left ovary: 4.0.Essure well positioned.Urinary sediment - on (b)(6) 2019: hg++ hc 8p/c; on (b)(6) 2021: normal.Weight (kg) - on (b)(6) 2019: 51 kg.White blood cell count - on (b)(6) 2021: 14600.X-ray - on an unknown date: essure dislocated, in eminence of to perforate the internal organs.Essure fragmented in several parts.; on (b)(6) 2020: essure in correct location in fallopian tubes.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.Https://by-arg8papp.De.Bayer.Cnb/img/tabs/tab_right_move.Gif most recent follow-up information incorporated above includes: on 24-feb-2022: quality safety evaluation of product technical complaint (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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Search Alerts/Recalls
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