| 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
Perforation (2001); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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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 breakage ('essure is fragmented in several parts') and device dislocation ('essure is not correctly located in the fallopian tubes') in a (b)(6) female patient who had essure (batch no.863680) inserted for contraception.The occurrence of additional non-serious events is detailed below.The patient's medical history included multigravida (4) and parity 3.In (b)(6) 2014, the patient experienced the first episode of pelvic pain ("strong pain below womb"), the first episode of dyspareunia ("strong pain during sexual intercourse") and vaginal discharge ("intense vaginal discharge with strong odor").On (b)(6) 2014, the patient had essure inserted.In 2017, the patient experienced the second episode of pelvic pain ("strong colic below womb, like stabbing pain, pelvic pain, sensation of uterus perforation"), breast pain ("mastalgia"), menorrhagia ("increase of menstrual flow and duration with clots"), headache ("strong headache"), the second episode of dyspareunia ("pain during and after sexual intercourse"), breast swelling ("breast swelling"), dizziness ("dizziness"), polymenorrhoea ("polymenorrhoea") and dysmenorrhoea ("dysmenorrhoea").On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), device dislocation (seriousness criterion medically significant), abdominal distension ("distension"), oedema ("edema"), pain in extremity ("pain in legs"), peripheral swelling ("swollen legs"), hypoaesthesia ("too much numbness"), uterine inflammation ("uterine inflammation"), tremor ("tremor"), back pain ("lumbar pain"), fatigue ("fatigue"), loss of libido ("absence of libido"), coital bleeding ("bleeding during and after sexual intercourse"), arthralgia ("joint pain"), mood altered ("frequent humor changes"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("liquid in the abdomen"), pain ("general pain") and diarrhoea ("intermittent diarrhea").The patient was treated with analgesics.Essure treatment was not changed.At the time of the report, the device breakage, device dislocation, vaginal discharge, the last episode of pelvic pain, breast pain, abdominal distension, oedema, menorrhagia, headache, pain in extremity, peripheral swelling, hypoaesthesia, uterine inflammation, tremor, back pain, fatigue, loss of libido, the last episode of dyspareunia, coital bleeding, arthralgia, mood altered, alopecia, adenomyosis, intra-abdominal fluid collection, pain, breast swelling, dizziness, polymenorrhoea, dysmenorrhoea and diarrhoea outcome was unknown.The reporter considered abdominal distension, adenomyosis, alopecia, arthralgia, back pain, breast pain, breast swelling, coital bleeding, device breakage, device dislocation, diarrhoea, dizziness, dysmenorrhoea, fatigue, headache, hypoaesthesia, intra-abdominal fluid collection, loss of libido, menorrhagia, mood altered, oedema, pain, pain in extremity, peripheral swelling, polymenorrhoea, tremor, uterine inflammation, vaginal discharge, the first episode of dyspareunia, the first episode of pelvic pain, the second episode of dyspareunia and the second episode of pelvic pain to be related to essure.The reporter commented: anteversoflexion uterus, no uterine cavity alteration, no difficulty during insertion.Diagnostic results (normal ranges are provided in parenthesis if available): human chorionic gonadotropin - on (b)(6) 2014: negative.Ultrasound scan - on (b)(6) 2020: symptoms are related to complication and local inflammatory process of essure.Dislocation provides a real risk of perforation, therefore, removal is important.X-ray - on (b)(6) 2020: essure is not correctly located in the fallopian tubes and it is fragmented in several parts.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 breakage ('essure is fragmented in several parts') and device dislocation ('essure is not correctly located in the fallopian tubes') in a 36-year-old female patient who had essure (batch no.863680-inv) inserted for contraception.The occurrence of additional non-serious events is detailed below.The patient's medical history included multigravida (4) and parity 3.In (b)(6) 2014, the patient experienced the first episode of pelvic pain ("strong pain below womb"), the first episode of dyspareunia ("strong pain during sexual intercourse") and vaginal discharge ("intense vaginal discharge with strong odor").On (b)(6) 2014, the patient had essure inserted.In 2017, the patient experienced the second episode of pelvic pain ("strong colic below womb, like stabbing pain, pelvic pain, sensation of uterus perforation"), breast pain ("mastalgia"), menorrhagia ("increase of menstrual flowand duration with clots"), headache ("strong headache"), the second episode of dyspareunia ("pain during and after sexual intercourse"), breast swelling ("breast swelling"), dizziness ("dizziness"), polymenorrhoea ("polymenorrhoea") and dysmenorrhoea ("dysmenorrhoea").On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), device dislocation (seriousness criterion medically significant), abdominal distension ("distension"), oedema ("edema"), pain in extremity ("pain in legs"), peripheral swelling ("swollen legs"), hypoaesthesia ("too much numbness"), uterine inflammation ("uterine inflammation"), tremor ("tremor"), back pain ("lumbar pain"), fatigue ("fatigue"), loss of libido ("absence of libido"), coital bleeding ("bleeding during and after sexual intercourse"), arthralgia ("joint pain"), mood altered ("frequent humor changes"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("liquid in the abdomen"), pain ("general pain") and diarrhoea ("intermittent diarrhea").The patient was treated with analgesics.Essure treatment was not changed.At the time of the report, the device breakage, device dislocation, vaginal discharge, the last episode of pelvic pain, breast pain, abdominal distension, oedema, menorrhagia, headache, pain in extremity, peripheral swelling, hypoaesthesia, uterine inflammation, tremor, back pain, fatigue, loss of libido, the last episode of dyspareunia, coital bleeding, arthralgia, mood altered, alopecia, adenomyosis, intra-abdominal fluid collection, pain, breast swelling, dizziness, polymenorrhoea, dysmenorrhoea and diarrhoea outcome was unknown.The reporter considered abdominal distension, adenomyosis, alopecia, arthralgia, back pain, breast pain, breast swelling, coital bleeding, device breakage, device dislocation, diarrhoea, dizziness, dysmenorrhoea, fatigue, headache, hypoaesthesia, intra-abdominal fluid collection, loss of libido, menorrhagia, mood altered, oedema, pain, pain in extremity, peripheral swelling, polymenorrhoea, tremor, uterine inflammation, vaginal discharge, the first episode of dyspareunia, the first episode of pelvic pain, the second episode of dyspareunia and the second episode of pelvic pain to be related to essure.The reporter commented: anteversoflexion uterus, no uterine cavity alteration, no difficulty during insertion.Diagnostic results (normal ranges are provided in parenthesis if available): human chorionic gonadotropin - on (b)(6) 2014: negative.Ultrasound scan - on (b)(6) 2020: symptoms are related to complication and local inflammatory process of essure.Dislocation provides a real risk of perforation, therefore, removal is important.X-ray - on (b)(6) 2020: essure is not correctly located in the fallopian tubes and it is fragmented in several parts.The bacth reported 863680 is not valid.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 29-jun-2020: quality-safety evaluation of ptc.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 is fragmented in several parts') and device dislocation ('essure is not correctly located in the fallopian tubes') in a 36-year-old female patient who had essure (batch no.863680-inv) inserted for contraception.The occurrence of additional non-serious events is detailed below.The patient's medical history included multigravida (4), parity 3 and multigravida.In (b)(6) 2014, the patient experienced the first episode of pelvic pain ("strong pain below womb"), the first episode of dyspareunia ("strong pain during sexual intercourse") and vaginal discharge ("intense vaginal discharge with strong odor").On (b)(6) 2014, the patient had essure inserted.In 2017, the patient experienced the second episode of pelvic pain ("strong colic below womb, like stabbing pain, pelvic pain, sensation of uterus perforation"), breast pain ("mastalgia"), menorrhagia ("increase of menstrual flow and duration with clots"), headache ("strong headache"), the second episode of dyspareunia ("pain during and after sexual intercourse"), breast swelling ("breast swelling"), dizziness ("dizziness"), polymenorrhoea ("polymenorrhoea") and dysmenorrhoea ("dysmenorrhoea").On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), device dislocation (seriousness criterion medically significant), abdominal distension ("distension"), oedema ("edema"), pain in extremity ("pain in legs"), peripheral swelling ("swollen legs"), hypoaesthesia ("too much numbness"), uterine inflammation ("uterine inflammation"), tremor ("tremor"), back pain ("lumbar pain"), fatigue ("fatigue"), loss of libido ("absence of libido"), coital bleeding ("bleeding during and after sexual intercourse"), arthralgia ("joint pain"), mood altered ("frequent humor changes"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("liquid in the abdomen"), pain ("general pain"), diarrhoea ("intermittent diarrhea"), anxiety ("anxiety ") and affect lability ("emotional lability").The patient was treated with analgesics and antiinflammatory agents.Essure treatment was not changed.At the time of the report, the device breakage, device dislocation, vaginal discharge, the last episode of pelvic pain, breast pain, abdominal distension, oedema, menorrhagia, headache, pain in extremity, peripheral swelling, hypoaesthesia, uterine inflammation, tremor, back pain, fatigue, loss of libido, the last episode of dyspareunia, coital bleeding, arthralgia, mood altered, alopecia, adenomyosis, intra-abdominal fluid collection, pain, breast swelling, dizziness, polymenorrhoea, dysmenorrhoea and diarrhoea outcome was unknown and the anxiety and affect lability had not resolved.The reporter considered abdominal distension, adenomyosis, affect lability, alopecia, anxiety, arthralgia, back pain, breast pain, breast swelling, coital bleeding, device breakage, device dislocation, diarrhoea, dizziness, dysmenorrhoea, fatigue, headache, hypoaesthesia, intra-abdominal fluid collection, loss of libido, menorrhagia, mood altered, oedema, pain, pain in extremity, peripheral swelling, polymenorrhoea, tremor, uterine inflammation, vaginal discharge, the first episode of dyspareunia, the first episode of pelvic pain, the second episode of dyspareunia and the second episode of pelvic pain to be related to essure.The reporter commented: anteversoflexion uterus, no uterine cavity alteration, no difficulty during insertion.Diagnostic results (normal ranges are provided in parenthesis if available): human chorionic gonadotropin - on (b)(6) 2014: negative.Ultrasound scan - on (b)(6) 2020: symptoms are related to complication and local inflammatory process of essure.Dislocation provides a real risk of perforation, therefore, removal is important.X-ray - on (b)(6) 2020: essure is not correctly located in the fallopian tubes and it is fragmented in several parts.The batch reported 863680 is not valid.Quality-safety evaluation of ptc: unable to confirm complaint.Amendment: the report was amended for the following reason: information from duplicate case (b)(4) has been transferred to this present case, including reporter (physician), medical history, treatment drug, events (anxiety and emotional lability).No new follow-up information was received from the reporter.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 is fragmented in several parts') and device dislocation ('essure is not correctly located in the fallopian tubes') in a 36-year-old female patient who had essure (batch no.863680-inv) inserted for contraception.The occurrence of additional non-serious events is detailed below.The patient's medical history included multigravida (4), parity 3 and multigravida.On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced the first episode of pelvic pain ("strong pain below womb"), the first episode of dyspareunia ("strong pain during sexual intercourse") and vaginal discharge ("intense vaginal discharge with strong odor").In 2017, the patient experienced the second episode of pelvic pain ("strong colic below womb, like stabbing pain, pelvic pain, sensation of uterus perforation"), breast pain ("mastalgia"), menorrhagia ("increase of menstrual flow and duration with clots"), headache ("strong headache"), the second episode of dyspareunia ("pain during and after sexual intercourse"), breast swelling ("breast swelling"), dizziness ("dizziness"), polymenorrhoea ("polymenorrhoea") and dysmenorrhoea ("dysmenorrhoea").On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), device dislocation (seriousness criterion medically significant), abdominal distension ("distension"), oedema ("edema"), pain in extremity ("pain in legs"), peripheral swelling ("swollen legs"), hypoaesthesia ("too much numbness"), uterine inflammation ("uterine inflammation"), tremor ("tremor"), back pain ("lumbar pain"), fatigue ("fatigue"), loss of libido ("absence of libido"), coital bleeding ("bleeding during and after sexual intercourse"), arthralgia ("joint pain"), mood altered ("frequent humor changes"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("liquid in the abdomen"), pain ("general pain"), diarrhoea ("intermittent diarrhea"), anxiety ("anxiety ") and affect lability ("emotional lability").The patient was treated with analgesics and antiinflammatory agents.Essure treatment was not changed.At the time of the report, the device breakage, device dislocation, vaginal discharge, the last episode of pelvic pain, breast pain, abdominal distension, oedema, menorrhagia, headache, pain in extremity, peripheral swelling, hypoaesthesia, uterine inflammation, tremor, back pain, fatigue, loss of libido, the last episode of dyspareunia, coital bleeding, arthralgia, mood altered, alopecia, adenomyosis, intra-abdominal fluid collection, pain, breast swelling, dizziness, polymenorrhoea, dysmenorrhoea and diarrhoea outcome was unknown and the anxiety and affect lability had not resolved.The reporter considered abdominal distension, adenomyosis, affect lability, alopecia, anxiety, arthralgia, back pain, breast pain, breast swelling, coital bleeding, device breakage, device dislocation, diarrhoea, dizziness, dysmenorrhoea, fatigue, headache, hypoaesthesia, intra-abdominal fluid collection, loss of libido, menorrhagia, mood altered, oedema, pain, pain in extremity, peripheral swelling, polymenorrhoea, tremor, uterine inflammation, vaginal discharge, the first episode of dyspareunia, the first episode of pelvic pain, the second episode of dyspareunia and the second episode of pelvic pain to be related to essure.The reporter commented: anteversoflexion uterus, no uterine cavity alteration, no difficulty during insertion.Diagnostic results (normal ranges are provided in parenthesis if available): human chorionic gonadotropin - on (b)(6) 2014: negative.Ultrasound scan - on (b)(6) 2020: symptoms are related to complication and local inflammatory process of essure.Dislocation provides a real risk of perforation, therefore, removal is important.X-ray - on (b)(6) 2020: essure is not correctly located in the fallopian tubes and it is fragmented in several parts.The bacth reported 863680 is not valid.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 is fragmented in several parts') and device dislocation ('essure is not correctly located in the fallopian tubes') in a 36-year-old female patient who had essure (batch no.863680-inv) inserted for contraception.The occurrence of additional non-serious events is detailed below.The patient's medical history included multigravida (4), parity 3 and multigravida.On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced the first episode of pelvic pain ("strong pain below womb"), the first episode of dyspareunia ("strong pain during sexual intercourse") and vaginal discharge ("intense vaginal discharge with strong odor").In 2017, the patient experienced the second episode of pelvic pain ("strong colic below womb, like stabbing pain, pelvic pain, sensation of uterus perforation"), breast pain ("mastalgia"), heavy menstrual bleeding ("increase of menstrual flowand duration with clots"), headache ("strong headache"), the second episode of dyspareunia ("pain during and after sexual intercourse"), breast swelling ("breast swelling"), dizziness ("dizziness"), polymenorrhoea ("polymenorrhoea") and dysmenorrhoea ("dysmenorrhoea").On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), device dislocation (seriousness criterion medically significant), abdominal distension ("distension"), oedema ("edema"), pain in extremity ("pain in legs"), peripheral swelling ("swollen legs"), hypoaesthesia ("too much numbness"), uterine inflammation ("uterine inflammation"), tremor ("tremor"), back pain ("lumbar pain"), fatigue ("fatigue"), loss of libido ("absence of libido"), coital bleeding ("bleeding during and after sexual intercourse"), arthralgia ("joint pain"), mood altered ("frequent humor changes"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("liquid in the abdomen"), pain ("general pain"), diarrhoea ("intermittent diarrhea"), anxiety ("anxiety ") and affect lability ("emotional lability").The patient was treated with analgesics and antiinflammatory agents.Essure treatment was not changed.At the time of the report, the device breakage, device dislocation, vaginal discharge, the last episode of pelvic pain, breast pain, abdominal distension, oedema, heavy menstrual bleeding, headache, pain in extremity, peripheral swelling, hypoaesthesia, uterine inflammation, tremor, back pain, fatigue, loss of libido, the last episode of dyspareunia, coital bleeding, arthralgia, mood altered, alopecia, adenomyosis, intra-abdominal fluid collection, pain, breast swelling, dizziness, polymenorrhoea, dysmenorrhoea and diarrhoea outcome was unknown and the anxiety and affect lability had not resolved.The reporter considered abdominal distension, adenomyosis, affect lability, alopecia, anxiety, arthralgia, back pain, breast pain, breast swelling, coital bleeding, device breakage, device dislocation, diarrhoea, dizziness, dysmenorrhoea, fatigue, headache, heavy menstrual bleeding, hypoaesthesia, intra-abdominal fluid collection, loss of libido, mood altered, oedema, pain, pain in extremity, peripheral swelling, polymenorrhoea, tremor, uterine inflammation, vaginal discharge, the first episode of dyspareunia, the first episode of pelvic pain, the second episode of dyspareunia and the second episode of pelvic pain to be related to essure.The reporter commented: anteversoflexion uterus, no uterine cavity alteration, no difficulty during insertion.Diagnostic results (normal ranges are provided in parenthesis if available): human chorionic gonadotropin - on (b)(6) 2014: negative.Smear cervix - on (b)(6) 2020: negative for malignancy.Ultrasound scan - on (b)(6) 2020: symptoms are related to complication and local inflammatory process of essure.Dislocation provides a real risk of perforation, therefore, removal is important.Ultrasound scan vagina - on (b)(6) 2020: uterine fibroids, bilateral intra-tubal devices, normal ovaries.Normal pelvic echographic appearance.X-ray - on (b)(6) 2020: essure is not correctly located in the fallopian tubes and it is fragmented in several parts.The bacth reported 863680 is not valid.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 10-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 is fragmented in several parts') and device dislocation ('essure is not correctly located in the fallopian tubes') in a 36-year-old female patient who had essure (batch no.863680-inv) inserted for contraception.The occurrence of additional non-serious events is detailed below.The patient's medical history included multigravida (4), parity 3 and multigravida.In (b)(6) 2014, the patient experienced the first episode of pelvic pain ("strong pain below womb"), the first episode of dyspareunia ("strong pain during sexual intercourse") and vaginal discharge ("intense vaginal discharge with strong odor").On (b)(6) 2014, the patient had essure inserted.In 2017, the patient experienced the second episode of pelvic pain ("strong colic below womb, like stabbing pain, pelvic pain, sensation of uterus perforation"), breast pain ("mastalgia"), heavy menstrual bleeding ("increase of menstrual flowand duration with clots"), headache ("strong headache"), the second episode of dyspareunia ("pain during and after sexual intercourse"), breast swelling ("breast swelling"), dizziness ("dizziness"), polymenorrhoea ("polymenorrhoea") and dysmenorrhoea ("dysmenorrhoea").On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), device dislocation (seriousness criterion medically significant), abdominal distension ("distension"), oedema ("edema"), pain in extremity ("pain in legs"), peripheral swelling ("swollen legs"), hypoaesthesia ("too much numbness"), uterine inflammation ("uterine inflammation"), tremor ("tremor"), back pain ("lumbar pain"), fatigue ("fatigue"), loss of libido ("absence of libido"), coital bleeding ("bleeding during and after sexual intercourse"), arthralgia ("joint pain"), mood altered ("frequent humor changes"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("liquid in the abdomen"), pain ("general pain"), diarrhoea ("intermittent diarrhea"), anxiety ("anxiety ") and affect lability ("emotional lability").The patient was treated with analgesics and antiinflammatory agents.Essure treatment was not changed.At the time of the report, the device breakage, device dislocation, vaginal discharge, the last episode of pelvic pain, breast pain, abdominal distension, oedema, heavy menstrual bleeding, headache, pain in extremity, peripheral swelling, hypoaesthesia, uterine inflammation, tremor, back pain, fatigue, loss of libido, the last episode of dyspareunia, coital bleeding, arthralgia, mood altered, alopecia, adenomyosis, intra-abdominal fluid collection, pain, breast swelling, dizziness, polymenorrhoea, dysmenorrhoea and diarrhoea outcome was unknown and the anxiety and affect lability had not resolved.The reporter considered abdominal distension, adenomyosis, affect lability, alopecia, anxiety, arthralgia, back pain, breast pain, breast swelling, coital bleeding, device breakage, device dislocation, diarrhoea, dizziness, dysmenorrhoea, fatigue, headache, heavy menstrual bleeding, hypoaesthesia, intra-abdominal fluid collection, loss of libido, mood altered, oedema, pain, pain in extremity, peripheral swelling, polymenorrhoea, tremor, uterine inflammation, vaginal discharge, the first episode of dyspareunia, the first episode of pelvic pain, the second episode of dyspareunia and the second episode of pelvic pain to be related to essure.The reporter commented: anteversoflexion uterus, no uterine cavity alteration, no difficulty during insertion.Diagnostic results (normal ranges are provided in parenthesis if available): human chorionic gonadotropin - on (b)(6) 2014: negative.Smear cervix - on (b)(6) 2020: negative for malignancy.Ultrasound scan - on (b)(6) 2020: symptoms are related to complication and local inflammatory process of essure.Dislocation provides a real risk of perforation, therefore, removal is important.Ultrasound scan vagina - on (b)(6) 2020: uterine fibroids, bilateral intra-tubal devices, normal ovaries.Normal pelvic echographic appearance.X-ray - on (b)(6) 2020: essure is not correctly located in the fallopian tubes and it is fragmented in several parts.The bacth reported 863680 is not valid.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 28-may-2021: two lab datas were added and update to imdrf/fda codes.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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