| 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
Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Death
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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)') in (b)(6) female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device material issue "essure fragmentation" (seriousness criterion medically significant).The patient's medical history included parity.In (b)(6) 2014, the patient had essure inserted.In (b)(6) 2017, the patient experienced headache ("cephalea"), menorrhagia ("menstrual flow increased with clots"), polymenorrhoea ("menstrual frequency increased"), abdominal pain lower ("lower abdomen pain (like cramps)"), dysmenorrhoea ("pain during menses"), vaginal discharge ("increase of vaginal secretion"), vulvovaginal pruritus ("vaginal pruritus"), diarrhoea ("intermittent and sporadic diarrhea associated to the menstrual cycle") and anxiety disorder ("anxiety disorder").On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant).Essure treatment was ongoing at the time of the report.At the time of the report, the device dislocation, headache, menorrhagia, polymenorrhoea, abdominal pain lower, dysmenorrhoea, vaginal discharge, vulvovaginal pruritus, diarrhoea and anxiety disorder had not resolved.The reporter considered abdominal pain lower, anxiety disorder, device dislocation, diarrhoea, dysmenorrhoea, headache, menorrhagia, polymenorrhoea, vaginal discharge and vulvovaginal pruritus to be related to essure.The reporter commented: after the insertion of essure, the consumer was discharged without complains.In (b)(6) 2017, she started experiencing lower abdomen pain and during the menstrual cycle.Because of this, she went to the hospital a few times (outpatient) and received anti-inflammatory and analgesic drugs, with partial improvement.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 dislocated (near to perfurate her internal organs)') and device breakage ('essure fragmentation') in a 36-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included multiparous.In (b)(6) 2014, the patient had essure inserted.In 2017, the patient experienced headache ("cephalea"), menorrhagia ("menstrual flow increased with clots"), polymenorrhoea ("menstrual frequency increased"), abdominal pain lower ("lower abdomen pain (like cramps)"), dysmenorrhoea ("pain during menses"), vaginal discharge ("increase of vaginal secretion"), vulvovaginal pruritus ("vaginal pruritus"), diarrhoea ("intermittent and sporadic diarrhea associated to the menstrual cycle") and anxiety disorder ("anxiety disorder").On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant) and device breakage (seriousness criterion medically significant).Essure treatment was ongoing at the time of the report.At the time of the report, the device dislocation, device breakage, headache, menorrhagia, polymenorrhoea, abdominal pain lower, dysmenorrhoea, vaginal discharge, vulvovaginal pruritus, diarrhoea and anxiety disorder had not resolved.The reporter considered abdominal pain lower, anxiety disorder, device breakage, device dislocation, diarrhoea, dysmenorrhoea, headache, menorrhagia, polymenorrhoea, vaginal discharge and vulvovaginal pruritus to be related to essure.The reporter commented: after the insertion of essure, the consumer was discharged without complains.In 2017, she started experiencing lower abdomen pain and during the menstrual cycle.Because of this, she went to the hospital a few times (outpatient) and received anti-inflammatory and analgesic drugs, with partial improvement.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 4-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 fatal cervix carcinoma ('malignant neoplasm of the cervix'), fatal acute kidney injury ('acute renal failure'), fatal pneumonia ('pneumonia'), fatal sepsis ('sepsis'), fatal septic shock ('septic shock'), device dislocation ('essure dislocated (near to perfurate her internal organs)') and device breakage ('essure fragmentation') in a 36-year-old female patient who had essure (batch no.863580) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included multi gravida and parity 5.On an unknown date, the patient had essure inserted.In 2017, the patient experienced headache ("cephalea"), bleeding menstrual heavy ("menstrual flow increased with clots"), polymenorrhoea ("menstrual frequency increased"), abdominal pain lower ("lower abdomen pain (like cramps) / severe cramps"), dysmenorrhoea ("pain during menses"), vaginal discharge abnormality ("increase of vaginal secretion"), vulvovaginal pruritus ("vaginal pruritus"), diarrhoea ("intermittent and sporadic diarrhea associated to the menstrual cycle") and anxiety disorder ("anxiety disorder").On an unknown date, the patient was found to have cervix carcinoma (seriousness criterion death) and experienced acute kidney injury (seriousness criterion death), pneumonia (seriousness criterion death), sepsis (seriousness criterion death), septic shock (seriousness criterion death), device dislocation (seriousness criterion medically significant), device breakage (seriousness criterion medically significant), breast pain ("mastalgia"), abdominal distension ("distention"), oedema ("edema"), prolonged menses ("menstruation up to 15 days"), pain in extremity ("leg pain"), peripheral swelling ("swollen leg"), paraesthesia ("tingling"), tremor ("tremors"), back pain ("lumbar pain"), pelvic pain ("pelvic pain"), uterine pain ("sensation of perforated uterus / pain"), fatigue ("fatigue"), loss of libido ("no libido"), dyspareunia ("pain during and after sexual intercourse"), coital bleeding ("bleeding during and after sexual intercourse"), uterine inflammation ("uterine inflammation"), arthralgia ("joint pain"), mood swings ("mood swings"), alopecia ("hair loss"), adenomyosis ("suspected adenomyosis"), intra-abdominal fluid collection ("fluid in abdomen"), pain ("generalized pain"), offensive vaginal discharge ("strong smell from vaginal discharge"), nervousness ("nervousness") and stress ("stress").Essure treatment was ongoing at the time of the report.By the time of death, the device dislocation, device breakage, headache, bleeding menstrual heavy, polymenorrhoea, abdominal pain lower, dysmenorrhoea, vaginal discharge abnormality, vulvovaginal pruritus, diarrhoea and anxiety disorder had not resolved and the breast pain, abdominal distension, oedema, prolonged menses, pain in extremity, peripheral swelling, paraesthesia, tremor, back pain, pelvic pain, uterine pain, fatigue, loss of libido, dyspareunia, coital bleeding, uterine inflammation, arthralgia, mood swings, alopecia, adenomyosis, intra-abdominal fluid collection, pain, offensive vaginal discharge, nervousness and stress outcome was unknown.The patient died on (b)(6) 2020 and the reported cause of death was malignant neoplasm of cervix uteri, acute renal failure, pneumonia, sepsis and septic shock.The reporter provided no causality assessment for acute kidney injury, cervix carcinoma, pneumonia, sepsis and septic shock with essure.The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, anxiety disorder, arthralgia, back pain, bleeding menstrual heavy, breast pain, coital bleeding, device breakage, device dislocation, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, headache, intra-abdominal fluid collection, loss of libido, mood swings, nervousness, oedema, pain, pain in extremity, paraesthesia, pelvic pain, peripheral swelling, polymenorrhoea, stress, tremor, uterine inflammation, uterine pain, vaginal discharge abnormality, vulvovaginal pruritus, offensive vaginal discharge and prolonged menses to be related to essure.The reporter commented: discrepancy noted regarding essure insertion date ((b)(6) 2012 and (b)(6) 2014).After the insertion of essure, the consumer was discharged without complains.In 2017, she started experiencing lower abdomen pain and during the menstrual cycle.Because of this, she went to the hospital a few times (outpatient) and received anti-inflammatory and analgesic drugs, with partial improvement.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: essure not incorrect position / near to perforate organs.Lot number: 863580 manufacturing date: 2011/05 expiration date: 2014/05 quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample could not be conducted, as no sample was available.Most recent follow-up information incorporated above includes: on (b)(6) 2021: new adverse events were received: malignant neoplasm of the cervix, acute renal failure, pneumonia, sepsis and septic shock, which led the patient to death.This case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and experienced device dislocation and device breakage.In the further course, it was reported that on (b)(6) 2020, at the age of 36, patient died.The autopsy results showed cervix carcinoma, acute renal failure, pneumonia, sepsis, and septic shock.Device dislocation and device breakage are anticipated in the reference safety information for essure.The fatal events cervix carcinoma, acute renal failure, pneumonia, sepsis, and septic shock are unanticipated.Factors that play an important role in the development of cervical cancer are sexual behavior, smoking and hpv infection.There is no evidence to date that essure may lead to development or worsening of cervix carcinoma.Therefore, a causal relationship between cervix carcinoma and essure can be excluded (unrelated).This case was provided with minimal information.However, a causal relationship between acute renal failure, pneumonia, sepsis, and septic shock and essure was considered unrelated, considering the natural course of patient´s malignancy as most plausible alternative explanation.Considering their nature, an inherent causality of essure to device dislocation and device breakage can formally not be excluded (related).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 fatal cervix carcinoma ('malignant neoplasm of the cervix'), fatal acute kidney injury ('acute renal failure'), fatal pneumonia ('pneumonia'), fatal sepsis ('sepsis'), fatal septic shock ('septic shock'), device dislocation ('essure dislocated (near to perfurate her internal organs)') and device breakage ('essure fragmentation') in a 36-year-old female patient who had essure (batch no.863580) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included multi gravida and parity 5.On an unknown date, the patient had essure inserted.In 2017, the patient experienced headache ("cephalea"), bleeding menstrual heavy ("menstrual flow increased with clots"), polymenorrhoea ("menstrual frequency increased"), abdominal pain lower ("lower abdomen pain (like cramps) / severe cramps"), dysmenorrhoea ("pain during menses"), vaginal discharge abnormality ("increase of vaginal secretion"), vulvovaginal pruritus ("vaginal pruritus"), diarrhoea ("intermittent and sporadic diarrhea associated to the menstrual cycle") and anxiety disorder ("anxiety disorder").On an unknown date, the patient was found to have cervix carcinoma (seriousness criterion death) and experienced acute kidney injury (seriousness criterion death), pneumonia (seriousness criterion death), sepsis (seriousness criterion death), septic shock (seriousness criterion death), device dislocation (seriousness criterion medically significant), device breakage (seriousness criterion medically significant), breast pain ("mastalgia"), abdominal distension ("distention"), oedema ("edema"), prolonged menses ("menstruation up to 15 days"), pain in extremity ("leg pain"), peripheral swelling ("swollen leg"), paraesthesia ("tingling"), tremor ("tremors"), back pain ("lumbar pain"), pelvic pain ("pelvic pain"), uterine pain ("sensation of perforated uterus / pain"), fatigue ("fatigue"), loss of libido ("no libido"), dyspareunia ("pain during and after sexual intercourse"), coital bleeding ("bleeding during and after sexual intercourse"), uterine inflammation ("uterine inflammation"), arthralgia ("joint pain"), mood swings ("mood swings"), alopecia ("hair loss"), adenomyosis ("suspected adenomyosis"), intra-abdominal fluid collection ("fluid in abdomen"), pain ("generalized pain"), offensive vaginal discharge ("strong smell from vaginal discharge"), nervousness ("nervousness") and stress ("stress").Essure treatment was ongoing at the time of the report.By the time of death, the device dislocation, device breakage, headache, bleeding menstrual heavy, polymenorrhoea, abdominal pain lower, dysmenorrhoea, vaginal discharge abnormality, vulvovaginal pruritus, diarrhoea and anxiety disorder had not resolved and the breast pain, abdominal distension, oedema, prolonged menses, pain in extremity, peripheral swelling, paraesthesia, tremor, back pain, pelvic pain, uterine pain, fatigue, loss of libido, dyspareunia, coital bleeding, uterine inflammation, arthralgia, mood swings, alopecia, adenomyosis, intra-abdominal fluid collection, pain, offensive vaginal discharge, nervousness and stress outcome was unknown.The patient died on (b)(6) 2020 and the reported cause of death was malignant neoplasm of cervix uteri, acute renal failure, pneumonia, sepsis and septic shock.The reporter provided no causality assessment for acute kidney injury, cervix carcinoma, pneumonia, sepsis and septic shock with essure.The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, anxiety disorder, arthralgia, back pain, bleeding menstrual heavy, breast pain, coital bleeding, device breakage, device dislocation, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, headache, intra-abdominal fluid collection, loss of libido, mood swings, nervousness, oedema, pain, pain in extremity, paraesthesia, pelvic pain, peripheral swelling, polymenorrhoea, stress, tremor, uterine inflammation, uterine pain, vaginal discharge abnormality, vulvovaginal pruritus, offensive vaginal discharge and prolonged menses to be related to essure.The reporter commented: discrepancy noted regarding essure insertion date ( (b)(6) 2012 and (b)(6) 2014).After the insertion of essure, the consumer was discharged without complains.In 2017, she started experiencing lower abdomen pain and during the menstrual cycle.Because of this, she went to the hospital a few times (outpatient) and received anti-inflammatory and analgesic drugs, with partial improvement.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: essure not incorrect position / near to perforate organs.Lot number: 863580, manufacturing date: 2011/05, expiration date: 2014/05.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample could not be conducted, as no sample was available.Most recent follow-up information incorporated above includes: on (b)(6) 2021: updated quality safety evaluation of ptc.This case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and experienced device dislocation and device breakage.In the further course, it was reported that on (b)(6) 2020, at the age of 36, patient died.The autopsy results showed cervix carcinoma, acute renal failure, pneumonia, sepsis, and septic shock.Device dislocation and device breakage are anticipated in the reference safety information for essure.The fatal events cervix carcinoma, acute renal failure, pneumonia, sepsis, and septic shock are unanticipated.Factors that play an important role in the development of cervical cancer are sexual behavior, smoking and hpv infection.There is no evidence to date that essure may lead to development or worsening of cervix carcinoma.Therefore, a causal relationship between cervix carcinoma and essure can be excluded (unrelated).This case was provided with minimal information.However, a causal relationship between acute renal failure, pneumonia, sepsis, and septic shock and essure was considered unrelated, considering the natural course of patient´s malignancy as most plausible alternative explanation.Considering their nature, an inherent causality of essure to device dislocation and device breakage can formally not be excluded (related).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 dislocated (near to perforate her internal organs)') and device breakage ('essure fragmentation') in a 36-year-old female patient who had essure (batch no.863580) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included multiparous and multi gravida.In (b)(6) 2012, the patient had essure inserted.In 2017, the patient experienced headache ("cephalea"), bleeding menstrual heavy ("menstrual flow increased with clots"), polymenorrhoea ("menstrual frequency increased"), abdominal pain lower ("lower abdomen pain (like cramps) / severe cramps"), dysmenorrhoea ("pain during menses"), vaginal discharge abnormality ("increase of vaginal secretion"), vulvovaginal pruritus ("vaginal pruritus"), diarrhoea ("intermittent and sporadic diarrhea associated to the menstrual cycle") and anxiety disorder ("anxiety disorder").On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), device breakage (seriousness criterion medically significant), breast pain ("mastalgia"), abdominal distension ("distention"), oedema ("edema"), prolonged menses ("menstruation up to 15 days"), pain in extremity ("leg pain"), peripheral swelling ("swollen leg"), paraesthesia ("tingling"), tremor ("tremors"), back pain ("lumbar pain"), pelvic pain ("pelvic pain"), uterine pain ("sensation of perforated uterus / pain"), fatigue ("fatigue"), loss of libido ("no libido"), dyspareunia ("pain during and after sexual intercourse"), coital bleeding ("bleeding during and after sexual intercourse"), uterine inflammation ("uterine inflammation"), arthralgia ("joint pain"), mood swings ("mood swings"), alopecia ("hair loss"), adenomyosis ("suspected adenomyosis"), intra-abdominal fluid collection ("fluid in abdomen"), pain ("generalized pain"), offensive vaginal discharge ("strong smell from vaginal discharge"), nervousness ("nervousness") and stress ("stress").Essure treatment was ongoing at the time of the report.At the time of the report, the device dislocation, device breakage, headache, bleeding menstrual heavy, polymenorrhoea, abdominal pain lower, dysmenorrhoea, vaginal discharge abnormality, vulvovaginal pruritus, diarrhoea and anxiety disorder had not resolved and the breast pain, abdominal distension, oedema, prolonged menses, pain in extremity, peripheral swelling, paraesthesia, tremor, back pain, pelvic pain, uterine pain, fatigue, loss of libido, dyspareunia, coital bleeding, uterine inflammation, arthralgia, mood swings, alopecia, adenomyosis, intra-abdominal fluid collection, pain, offensive vaginal discharge, nervousness and stress outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, anxiety disorder, arthralgia, back pain, bleeding menstrual heavy, breast pain, coital bleeding, device breakage, device dislocation, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, headache, intra-abdominal fluid collection, loss of libido, mood swings, nervousness, oedema, pain, pain in extremity, paraesthesia, pelvic pain, peripheral swelling, polymenorrhoea, stress, tremor, uterine inflammation, uterine pain, vaginal discharge abnormality, vulvovaginal pruritus, offensive vaginal discharge and prolonged menses to be related to essure.The reporter commented: insertion date also reported as (b)(6) 2014.After the insertion of essure, the consumer was discharged without complains.In 2017, she started experiencing lower abdomen pain and during the menstrual cycle.Because of this, she went to the hospital a few times (outpatient) and received anti-inflammatory and analgesic drugs, with partial improvement.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: essure not incorrect position / near to perforate organs.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 16-mar-2021: insertion date updated.Reporter, medical history, lab data, lot number (863580) and events mastalgia, distention, edema, menstruation up to 15 days, leg pain, swollen leg, tingling, lumbar pain, pelvic pain, sensation of perforated uterus / pain, fatigue, no libido, pain during and after sexual intercourse, bleeding during and after sexual intercourse, uterine inflammation, joint pain, mood swings, hair loss, suspected adenomyosis, fluid in abdomen, generalized pain, strong smell from vaginal discharge, nervousness and stress added.We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('essure dislocated (near to perfurate her internal organs)') and device breakage ('essure fragmentation') in a 36-year-old female patient who had essure (batch no.863580) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included multiparous and multi gravida.In (b)(6) 2012, the patient had essure inserted.In 2017, the patient experienced headache ("cephalea"), bleeding menstrual heavy ("menstrual flow increased with clots"), polymenorrhoea ("menstrual frequency increased"), abdominal pain lower ("lower abdomen pain (like cramps) / severe cramps"), dysmenorrhoea ("pain during menses"), vaginal discharge abnormality ("increase of vaginal secretion"), vulvovaginal pruritus ("vaginal pruritus"), diarrhoea ("intermittent and sporadic diarrhea associated to the menstrual cycle") and anxiety disorder ("anxiety disorder").On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), device breakage (seriousness criterion medically significant), breast pain ("mastalgia"), abdominal distension ("distention"), oedema ("edema"), prolonged menses ("menstruation up to 15 days"), pain in extremity ("leg pain"), peripheral swelling ("swollen leg"), paraesthesia ("tingling"), tremor ("tremors"), back pain ("lumbar pain"), pelvic pain ("pelvic pain"), uterine pain ("sensation of perforated uterus / pain"), fatigue ("fatigue"), loss of libido ("no libido"), dyspareunia ("pain during and after sexual intercourse"), coital bleeding ("bleeding during and after sexual intercourse"), uterine inflammation ("uterine inflammation"), arthralgia ("joint pain"), mood swings ("mood swings"), alopecia ("hair loss"), adenomyosis ("suspected adenomyosis"), intra-abdominal fluid collection ("fluid in abdomen"), pain ("generalized pain"), offensive vaginal discharge ("strong smell from vaginal discharge"), nervousness ("nervousness") and stress ("stress").Essure treatment was ongoing at the time of the report.At the time of the report, the device dislocation, device breakage, headache, bleeding menstrual heavy, polymenorrhoea, abdominal pain lower, dysmenorrhoea, vaginal discharge abnormality, vulvovaginal pruritus, diarrhoea and anxiety disorder had not resolved and the breast pain, abdominal distension, oedema, prolonged menses, pain in extremity, peripheral swelling, paraesthesia, tremor, back pain, pelvic pain, uterine pain, fatigue, loss of libido, dyspareunia, coital bleeding, uterine inflammation, arthralgia, mood swings, alopecia, adenomyosis, intra-abdominal fluid collection, pain, offensive vaginal discharge, nervousness and stress outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, anxiety disorder, arthralgia, back pain, bleeding menstrual heavy, breast pain, coital bleeding, device breakage, device dislocation, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, headache, intra-abdominal fluid collection, loss of libido, mood swings, nervousness, oedema, pain, pain in extremity, paraesthesia, pelvic pain, peripheral swelling, polymenorrhoea, stress, tremor, uterine inflammation, uterine pain, vaginal discharge abnormality, vulvovaginal pruritus, offensive vaginal discharge and prolonged menses to be related to essure.The reporter commented: insertion date also reported as (b)(6) 2014.After the insertion of essure, the consumer was discharged without complains.In 2017, she started experiencing lower abdomen pain and during the menstrual cycle.Because of this, she went to the hospital a few times (outpatient) and received anti-inflammatory and analgesic drugs, with partial improvement.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: essure not incorrect position / near to perforate organs.Lot number: 863580 manufacturing date: 2011/05 expiration date: 2014/05.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample could not be conducted, as no sample was available.Most recent follow-up information incorporated above includes: on 21-mar-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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