| 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); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Genital Bleeding (4507); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 01/01/2017 |
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Event Type
Injury
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Event Description
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('essure found fragmented') and device dislocation ('left essure did not find/ right essure micro-insert found in wrong position in fallopian tube') in a (b)(6) female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included menarche, pregnancy and multiparous.Concomitant products included medroxyprogesterone acetate (depo provera) for contraception.In (b)(6) 2014, the patient had essure inserted.In 2017, the patient experienced device breakage (seriousness criterion medically significant), device dislocation (seriousness criterion medically significant), headache ("cephalea"), nausea ("nausea"), menorrhagia ("heavy and prolonged menstruation with clots"), pelvic pain ("pelvic pain"), back pain ("lumbar pain"), dysmenorrhoea ("menstrual pain"), diarrhoea ("intermittent diarrhea") and anxiety ("anxiety").On (b)(6) 2019, the patient was found to have uterine leiomyoma ("uterine myoma 1,3 x 1,2 cm").Essure treatment was not changed.At the time of the report, the device breakage, device dislocation, headache, nausea, menorrhagia, pelvic pain, back pain, dysmenorrhoea, diarrhoea, anxiety and uterine leiomyoma had not resolved.The reporter considered anxiety, back pain, device breakage, device dislocation, diarrhoea, dysmenorrhoea, headache, menorrhagia, nausea, pelvic pain and uterine leiomyoma to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound scan - on (b)(6) 2019: left essure did not find; on (b)(6) 2019: uterine myoma 1,3 x 1,2 cm.X-ray - on (b)(6) 2019: essure found in wrong position in fallopian tube and fragmented; left essure did not find.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 breakage ('essure found fragmented') and device dislocation ('left essure did not find/ right essure micro-insert found in wrong position in fallopian tube') in a 39-year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included menarche, gravida ii and parity 2.Concomitant products included medroxyprogesterone acetate (depo provera) for contraception.In (b)(6) 2014, the patient had essure inserted.In 2017, the patient experienced device breakage (seriousness criterion medically significant), device dislocation (seriousness criterion medically significant), headache ("cephalea"), nausea ("nausea"), menorrhagia ("heavy and prolonged menstruation with clots"), pelvic pain ("pelvic pain"), back pain ("lumbar pain"), dysmenorrhoea ("menstrual pain"), diarrhoea ("intermittent diarrhea") and anxiety ("anxiety").On (b)(6) 2019, the patient was found to have uterine leiomyoma ("uterine myoma 1,3 x 1,2 cm").Essure treatment was not changed.At the time of the report, the device breakage, device dislocation, headache, nausea, menorrhagia, pelvic pain, back pain, dysmenorrhoea, diarrhoea, anxiety, and uterine leiomyoma had not resolved.The reporter considered anxiety, back pain, device breakage, device dislocation, diarrhoea, dysmenorrhoea, headache, menorrhagia, nausea, pelvic pain, and uterine leiomyoma to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound scan - on (b)(6) 2019: uterine myoma 1,3 x 1,2 cm; on (b)(6) 2019: left essure did not find.X-ray - on (b)(6) 2019: essure found in wrong position in fallopian tube and fragmented; left essure did not find.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 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 breakage ('essure found fragmented'), device dislocation ('left essure did not find/ right essure micro-insert found in wrong position in fallopian tube'), uterine inflammation ('uterine inflammation') and uterine haemorrhage ('increased uterine bleeding') in a 39-year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included menarche, gravida ii and parity 2.Concomitant products included medroxyprogesterone acetate (depo provera) for contraception.In february 2014, the patient had essure inserted.In 2017, the patient experienced device breakage (seriousness criterion medically significant), device dislocation (seriousness criterion medically significant), headache ("cephalea"), nausea ("nausea"), heavy menstrual bleeding ("heavy and prolonged menstruation with clots / increased menstrual flow (up to 15 days of menstruation)"), pelvic pain ("pelvic pain"), back pain ("lumbar pain"), dysmenorrhoea ("menstrual pain"), diarrhoea ("intermitent diarrhea") and anxiety ("anxiety").On (b)(6) 2019, the patient was found to have uterine leiomyoma ("uterine myoma 1,3 x 1,2 cm").On (b)(6) 2020, the patient experienced keratoconus ("keratoconus").On (b)(6) 2020, the patient experienced uterine haemorrhage (seriousness criterion medically significant).On an unknown date, the patient experienced abdominal pain lower ("severe cramps in the lower abdomen, as twinge"), breast pain ("mastalgia"), abdominal distension ("distension"), oedema ("oedema"), pain in extremity ("leg pain"), peripheral swelling ("swollen legs"), paraesthesia ("tingling in the legs"), tremor ("tremors"), uterine pain ("sensation of perforation of the uterus"), fatigue ("fatigue"), loss of libido ("lack of libido"), dyspareunia ("pain during and after sexual intercourse"), coital bleeding ("bleeding during and after sexual intercourse"), uterine inflammation (seriousness criterion medically significant), arthralgia ("joint pain"), mood swings ("constant mood swings"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("fluid in the abdomen"), pain ("generalized pain"), vaginal discharge ("strong odor from the vaginal fluid") and depression ("depression").Essure treatment was not changed.At the time of the report, the device breakage, device dislocation, headache, nausea, heavy menstrual bleeding, pelvic pain, back pain, dysmenorrhoea, diarrhoea, anxiety and uterine leiomyoma had not resolved and the abdominal pain lower, breast pain, abdominal distension, oedema, pain in extremity, peripheral swelling, paraesthesia, tremor, uterine pain, fatigue, loss of libido, dyspareunia, coital bleeding, uterine inflammation, arthralgia, mood swings, alopecia, adenomyosis, intra-abdominal fluid collection, pain, vaginal discharge, uterine haemorrhage, keratoconus and depression outcome was unknown.The reporter provided no causality assessment for keratoconus with essure.The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, anxiety, arthralgia, back pain, breast pain, coital bleeding, depression, device breakage, device dislocation, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, headache, heavy menstrual bleeding, intra-abdominal fluid collection, loss of libido, mood swings, nausea, oedema, pain, pain in extremity, paraesthesia, pelvic pain, peripheral swelling, tremor, uterine haemorrhage, uterine inflammation, uterine leiomyoma, uterine pain and vaginal discharge to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound scan - on (b)(6) 2019: uterine myoma 1,3 x 1,2 cm; on (b)(6) 2019: left essure did not find.Ultrasound scan vagina - on (b)(6) 2020: uterus in retroversoflexion, enlarged, with homogeneous myometrium and several myomas, regular endometrium with secretory aspect, probable endometrial polyp, ovaries with normal appearance and mixed texture.X-ray - on (b)(6) 2019: essure found in wrong position in fallopian tube and fragmented; left essure did not find.X-ray of pelvis and hip - on (b)(6) 2020: parallel pelvic linear images, compatible with intra-tubal devices.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: 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 breakage ('essure found fragmented'), device dislocation ('left essure did not find/ right essure micro-insert found in wrong position in fallopian tube'), uterine inflammation ('uterine inflammation') and uterine haemorrhage ('increased uterine bleeding') in a 39-year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included menarche, gravida ii and parity 2.Concomitant products included medroxyprogesterone acetate (depo provera) for contraception.In (b)(6) 2014, the patient had essure inserted.In 2017, the patient experienced device breakage (seriousness criterion medically significant), device dislocation (seriousness criterion medically significant), headache ("cephalea"), nausea ("nausea"), heavy menstrual bleeding ("heavy and prolonged menstruation with clots / increased menstrual flow (up to 15 days of menstruation)"), pelvic pain ("pelvic pain"), back pain ("lumbar pain"), dysmenorrhoea ("menstrual pain"), diarrhoea ("intermitent diarrhea") and anxiety ("anxiety").On (b)(6) 2019, the patient was found to have uterine leiomyoma ("uterine myoma 1,3 x 1,2 cm").On (b)(6) 2020, the patient experienced keratoconus ("keratoconus").On (b)(6) 2020, the patient experienced uterine haemorrhage (seriousness criterion medically significant).On an unknown date, the patient experienced abdominal pain lower ("severe cramps in the lower abdomen, as twinge"), breast pain ("mastalgia"), abdominal distension ("distension"), oedema ("oedema"), pain in extremity ("leg pain"), peripheral swelling ("swollen legs"), paraesthesia ("tingling in the legs"), tremor ("tremors"), uterine pain ("sensation of perforation of the uterus"), fatigue ("fatigue"), loss of libido ("lack of libido"), dyspareunia ("pain during and after sexual intercourse"), coital bleeding ("bleeding during and after sexual intercourse"), uterine inflammation (seriousness criterion medically significant), arthralgia ("joint pain"), mood swings ("constant mood swings"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("fluid in the abdomen"), pain ("generalized pain"), vaginal discharge ("strong odor from the vaginal fluid") and depression ("depression").Essure treatment was not changed.At the time of the report, the device breakage, device dislocation, headache, nausea, heavy menstrual bleeding, pelvic pain, back pain, dysmenorrhoea, diarrhoea, anxiety and uterine leiomyoma had not resolved and the abdominal pain lower, breast pain, abdominal distension, oedema, pain in extremity, peripheral swelling, paraesthesia, tremor, uterine pain, fatigue, loss of libido, dyspareunia, coital bleeding, uterine inflammation, arthralgia, mood swings, alopecia, adenomyosis, intra-abdominal fluid collection, pain, vaginal discharge, uterine haemorrhage, keratoconus and depression outcome was unknown.The reporter provided no causality assessment for keratoconus with essure.The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, anxiety, arthralgia, back pain, breast pain, coital bleeding, depression, device breakage, device dislocation, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, headache, heavy menstrual bleeding, intra-abdominal fluid collection, loss of libido, mood swings, nausea, oedema, pain, pain in extremity, paraesthesia, pelvic pain, peripheral swelling, tremor, uterine haemorrhage, uterine inflammation, uterine leiomyoma, uterine pain and vaginal discharge to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound scan - on (b)(6) 2019: uterine myoma 1,3 x 1,2 cm; on (b)(6) 2019: left essure did not find.Ultrasound scan vagina - on (b)(6) 2020: uterus in retroversoflexion, enlarged, with homogeneous myometrium and several myomas, regular endometrium with secretory aspect, probable endometrial polyp, ovaries with normal appearance and mixed texture.X-ray - on (b)(6) 2019: essure found in wrong position in fallopian tube and fragmented; left essure did not find.X-ray of pelvis and hip - on (b)(6) 2020: parallel pelvic linear images, compatible with intra-tubal devices.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2021: lab data and the following adverse events were received: abdominal pain lower, mastalgia, distension, oedema, leg pain, swollen legs, tingling in the legs, tremor, uterine pain, fatigue, lack of libido, dyspareunia, bleeding during and after sexual intercourse, uterine inflammation, arthralgia, mood swings, hair loss, suspicion of adenomyosis, fluid in the abdomen, generalized pain, strong odor from the vaginal fluid, uterine bleeding, keratoconus, depression.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 breakage ('essure found fragmented'), device dislocation ('left essure did not find/ right essure micro-insert found in wrong position in fallopian tube'), uterine inflammation ('uterine inflammation') and uterine haemorrhage ('increased uterine bleeding') in a 39-year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included menarche, gravida ii and parity 2.Concomitant products included medroxyprogesterone acetate (depo provera) for contraception.In (b)(6) 2014, the patient had essure inserted.In 2017, the patient experienced device breakage (seriousness criteria hospitalization, medically significant and intervention required), device dislocation (seriousness criterion medically significant), headache ("cephalea"), nausea ("nausea"), heavy menstrual bleeding ("heavy and prolonged menstruation with clots / increased menstrual flow (up to 15 days of menstruation)"), pelvic pain ("pelvic pain, stinging or needling sensation in the pelvic region"), back pain ("lumbar pain"), dysmenorrhoea ("menstrual pain"), diarrhoea ("intermitent diarrhea"), anxiety ("anxiety / anguish") and polymenorrhagia ("increased flow and frequency of menstruation including clots").On (b)(6) 2019, the patient was found to have uterine leiomyoma ("uterine myoma 1,3 x 1,2 cm").On (b)(6) 2020, the patient experienced keratoconus ("keratoconus").On (b)(6) 2020, the patient experienced uterine haemorrhage (seriousness criterion medically significant).On an unknown date, the patient experienced uterine inflammation (seriousness criterion medically significant), abdominal pain lower ("severe cramps in the lower abdomen, as twinge"), breast pain ("mastalgia"), abdominal distension ("distension"), oedema ("oedema"), pain in extremity ("leg pain"), peripheral swelling ("swollen legs"), paraesthesia ("tingling in the legs"), tremor ("tremors"), uterine pain ("sensation of perforation of the uterus"), fatigue ("fatigue"), loss of libido ("lack of libido"), dyspareunia ("pain during and after sexual intercourse"), coital bleeding ("bleeding during and after sexual intercourse"), arthralgia ("joint pain"), mood swings ("constant mood swings"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("fluid in the abdomen"), pain ("generalized pain"), vaginal discharge ("strong odor from the vaginal fluid"), depression ("depression") and ovarian cyst ("left ovarian folicular cyst").The patient was hospitalized from (b)(6) 2021.The patient was treated with medroxyprogesterone (medroxiprogesterona) and surgery (essure removal via tota histerectomy and salpingectomy on (b)(6) 2021).Essure was removed on (b)(6) 2021.At the time of the report, the device breakage, device dislocation, headache, nausea, heavy menstrual bleeding, pelvic pain, back pain, dysmenorrhoea, diarrhoea, anxiety and uterine leiomyoma had not resolved and the uterine inflammation, abdominal pain lower, breast pain, abdominal distension, oedema, pain in extremity, peripheral swelling, paraesthesia, tremor, uterine pain, fatigue, loss of libido, dyspareunia, coital bleeding, arthralgia, mood swings, alopecia, adenomyosis, intra-abdominal fluid collection, pain, vaginal discharge, uterine haemorrhage, keratoconus, depression and polymenorrhagia outcome was unknown.The reporter provided no causality assessment for keratoconus with essure.The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, anxiety, arthralgia, back pain, breast pain, coital bleeding, depression, device breakage, device dislocation, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, headache, heavy menstrual bleeding, intra-abdominal fluid collection, loss of libido, mood swings, nausea, oedema, ovarian cyst, pain, pain in extremity, paraesthesia, pelvic pain, peripheral swelling, polymenorrhagia, tremor, uterine haemorrhage, uterine inflammation, uterine leiomyoma, uterine pain and vaginal discharge to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound scan - on (b)(6) 2019: uterine myoma 1,3 x 1,2 cm; on (b)(6) 2019: left essure did not find; on (b)(6) 2021: two thin and elongated hypercoic structures, 2.6 cm in length compatible with the essure devices located at the level of the uterine horns were observed, uterus with heterogeneous myometrium and several myomas (perhaps adenomyosis), the several with normal aspects, left ovarian with a dominant follicle.Ultrasound scan vagina - on an unknown date: the left device does not appear in exam; on (b)(6) 2020: uterus in retroversoflexion, enlarged, with homogeneous myometrium and several myomas, regular endometrium with secretory aspect, probable endometrial polyp, ovaries with normal appearance and mixed texture.Two thin and elongated hypercoic structures, 2.6 cm in length compatible with the essure devices located at the level of the uterine horns were observed.X-ray - on an unknown date: the left device does not appear in exam; on (b)(6) 2019: essure found in wrong position in fallopian tube and fragmented; left essure did not find.X-ray of pelvis and hip - on (b)(6) 2020: parallel pelvic linear images, compatible with intra-tubal devices.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 2-jul-2021: the follow information were updated lab data, treatment product, essure stop date, action item with drug updated to drug withdrawn, polymenorrhagia, follicular cyst of ovary.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 breakage ('essure found fragmented'), device dislocation ('left essure did not find/ right essure micro-insert found in wrong position in fallopian tube'), uterine haemorrhage ('increased uterine bleeding') and uterine inflammation ('uterine inflammation') in a 39-year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included menarche, gravida ii and parity 2.Concomitant products included medroxyprogesterone acetate (depo provera) for contraception.In (b)(6) 2014, the patient had essure inserted.In 2017, the patient experienced device breakage (seriousness criteria hospitalization, medically significant and intervention required), device dislocation (seriousness criterion medically significant), headache ("cephalea"), nausea ("nausea"), heavy menstrual bleeding ("heavy and prolonged menstruation with clots / increased menstrual flow (up to 15 days of menstruation)"), pelvic pain ("pelvic pain, stinging or needling sensation in the pelvic region"), back pain ("lumbar pain"), dysmenorrhoea ("menstrual pain"), diarrhoea ("intermitent diarrhea"), anxiety ("anxiety / anguish") and polymenorrhagia ("increased flow and frequency of menstruation including clots").On (b)(6) 2019, the patient was found to have uterine leiomyoma ("uterine myoma 1,3 x 1,2 cm").On (b)(6) 2020, the patient experienced keratoconus ("keratoconus").On (b)(6) 2020, the patient experienced uterine haemorrhage (seriousness criterion medically significant).On an unknown date, the patient experienced uterine inflammation (seriousness criterion medically significant), abdominal pain lower ("severe cramps in the lower abdomen, as twinge"), breast pain ("mastalgia"), abdominal distension ("distension"), oedema ("oedema"), pain in extremity ("leg pain"), peripheral swelling ("swollen legs"), paraesthesia ("tingling in the legs"), tremor ("tremors"), uterine pain ("sensation of perforation of the uterus"), fatigue ("fatigue"), loss of libido ("lack of libido"), dyspareunia ("pain during and after sexual intercourse"), coital bleeding ("bleeding during and after sexual intercourse"), arthralgia ("joint pain"), mood swings ("constant mood swings"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("fluid in the abdomen"), pain ("generalized pain"), vaginal discharge ("strong odor from the vaginal fluid"), depression ("depression") and ovarian cyst ("left ovarian folicular cyst").The patient was hospitalized from (b)(6) 2021 to (b)(6) 2021.The patient was treated with medroxyprogesterone (medroxiprogesterona) and surgery (essure removal via tota histerectomy and salpingectomy on (b)(6) 2021).Essure was removed on (b)(6) 2021.At the time of the report, the device breakage, device dislocation, headache, nausea, heavy menstrual bleeding, pelvic pain, back pain, dysmenorrhoea, diarrhoea, anxiety and uterine leiomyoma had not resolved and the uterine haemorrhage, uterine inflammation, abdominal pain lower, breast pain, abdominal distension, oedema, pain in extremity, peripheral swelling, paraesthesia, tremor, uterine pain, fatigue, loss of libido, dyspareunia, coital bleeding, arthralgia, mood swings, alopecia, adenomyosis, intra-abdominal fluid collection, pain, vaginal discharge, keratoconus, depression and polymenorrhagia outcome was unknown.The reporter provided no causality assessment for keratoconus with essure.The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, anxiety, arthralgia, back pain, breast pain, coital bleeding, depression, device breakage, device dislocation, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, headache, heavy menstrual bleeding, intra-abdominal fluid collection, loss of libido, mood swings, nausea, oedema, ovarian cyst, pain, pain in extremity, paraesthesia, pelvic pain, peripheral swelling, polymenorrhagia, tremor, uterine haemorrhage, uterine inflammation, uterine leiomyoma, uterine pain and vaginal discharge to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound scan - on (b)(6) 2019: uterine myoma 1,3 x 1,2 cm; on (b)(6) 2019: left essure did not find; on (b)(6) 2021: two thin and elongated hypercoic structures, 2.6 cm in length compatible with the essure devices located at the level of the uterine horns were observed, uterus with heterogeneous myometrium and several myomas (perhaps adenomyosis), the several with normal aspects, left ovarian with a dominant follicle.Ultrasound scan vagina - on an unknown date: the left device does not appear in exam; on (b)(6) 2020: uterus in retroversoflexion, enlarged, with homogeneous myometrium and several myomas, regular endometrium with secretory aspect, probable endometrial polyp, ovaries with normal appearance and mixed texture.Two thin and elongated hypercoic structures, 2.6 cm in length compatible with the essure devices located at the level of the uterine horns were observed.X-ray - on an unknown date: the left device does not appear in exam; on (b)(6) 2019: essure found in wrong position in fallopian tube and fragmented; left essure did not find.X-ray of pelvis and hip - on (b)(6) 2020: parallel pelvic linear images, compatible with intra-tubal devices.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-jul-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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