| Model Number ESS305 |
| Device Problems
Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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| Patient Problems
Bacterial Infection (1735); Contusion (1787); Fatigue (1849); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Perforation (2001); Rash (2033); Uterine Perforation (2121); Visual Impairment (2138); Confusion/ Disorientation (2553); Weight Changes (2607); Heavier Menses (2666); Foreign Body In Patient (2687)
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| Event Date 03/28/2017 |
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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 fallopian tube perforation ("perforation (fallopian tube)") and genital haemorrhage ("heavy and persistent bleeding") in a (b)(6)-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included body mass index normal.Concomitant products included naproxen sodium (midol extended relief caplet).On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced premature menopause ("hormonal changes describe: early menopause"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia"), bacterial vaginosis ("bacterial vaginosis"), contusion ("rashes or skin conditions type: bruising"), bladder disorder ("bladder or urinary problems or changes"), urinary tract disorder ("bladder or urinary problems or changes"), migraine ("migraines"), headache ("headaches"), nausea ("nausea"), tooth disorder ("dental problems"), feeling abnormal ("neurological conditions or problems type: brain fog"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), visual impairment ("vision/eye problems type: vision is damaged"), fatigue ("fatigue"), weight increased ("weight gain"), vulvovaginal pain ("vaginal pain") and back pain ("lower back region").On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), abdominal pain ("severe abdominal cramping"), pelvic pain ("severe pelvic cramping/ chronic pelvic pain"), alopecia ("hair loss") and hypersensitivity ("allergic reactions").The patient was treated with surgery (salpingectomy (bilateral removal of fallopian tubes),).Essure was removed.At the time of the report, the fallopian tube perforation, genital haemorrhage, abdominal pain, hypersensitivity, premature menopause, vaginal haemorrhage, menorrhagia, bacterial vaginosis, contusion, bladder disorder, urinary tract disorder, migraine, headache, nausea, tooth disorder, dyspareunia, visual impairment, fatigue, weight increased and vulvovaginal pain outcome was unknown and the pelvic pain, alopecia, feeling abnormal, dysmenorrhoea and back pain was resolving.The reporter considered abdominal pain, alopecia, back pain, bacterial vaginosis, bladder disorder, contusion, dysmenorrhoea, dyspareunia, fallopian tube perforation, fatigue, feeling abnormal, genital haemorrhage, headache, hypersensitivity, menorrhagia, migraine, nausea, pelvic pain, premature menopause, tooth disorder, urinary tract disorder, vaginal haemorrhage, visual impairment, vulvovaginal pain and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.8 kg/sqm.Hysterosalpingogram - on (b)(6) 2014: total bilateral occlusion.Quality-safety evaluation of ptc: no sample available for this investigation.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.The reported medical events are not necessarily indicative of a quality defect.As no batch number was reported a technical batch investigation and a review of similar ae case reports is not possible.No complaint sample was provided for further investigation therefore the complaint could not be evaluated in greater detail.The technical assessment concluded a quality defect was not confirmed but considered plausible.No specific quality issue was defined, therefore no meddra llt can be provided.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.Most recent follow-up information incorporated above includes: on 28-feb-2018: plaintiff fact sheet was received - reporter and patient demographic added.The following events were provided: premature menopause, abnormal bleeding (vaginal),menorrhagia, bacterial vaginosis, bruising, bladder disorder, urinary tract disorder, migraines, headaches, nausea, dental problems, mental fogginess, dysmenorrhea (cramping), dyspareunia, blindness, fatigue, weight gain, vaginal pain, lower back pain, fallopian tube perforation, (b)(4).Incident: no lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("perforation (fallopian tube)") and genital haemorrhage ("heavy and persistent bleeding") in a 29-year-old female patient who had essure (batch no.A90480) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included body mass index normal and urinary frequency.Concomitant products included naproxen sodium (midol extended relief caplet).On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced premature menopause ("hormonal changes describe: early menopause"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia"), bacterial vaginosis ("bacterial vaginosis"), contusion ("rashes or skin conditions type: bruising"), bladder disorder ("bladder or urinary problems or changes"), urinary tract disorder ("bladder or urinary problems or changes"), migraine ("migraines"), headache ("headaches"), nausea ("nausea"), tooth disorder ("dental problems"), feeling abnormal ("neurological conditions or problems type: brain fog"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), visual impairment ("vision/eye problems type: vision is damaged"), fatigue ("fatigue"), weight increased ("weight gain"), vulvovaginal pain ("vaginal pain") and back pain ("lower back region").On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), abdominal pain ("severe abdominal cramping"), pelvic pain ("severe pelvic cramping/ chronic pelvic pain"), alopecia ("hair loss") and hypersensitivity ("allergic reactions").The patient was treated with surgery (salpingectomy (bilateral removal of fallopian tubes),).Essure was removed on (b)(6) 2017.At the time of the report, the fallopian tube perforation, genital haemorrhage, abdominal pain, hypersensitivity, premature menopause, vaginal haemorrhage, menorrhagia, bacterial vaginosis, contusion, bladder disorder, urinary tract disorder, migraine, headache, nausea, tooth disorder, dyspareunia, visual impairment, fatigue, weight increased and vulvovaginal pain outcome was unknown and the pelvic pain, alopecia, feeling abnormal, dysmenorrhoea and back pain was resolving.The reporter considered abdominal pain, alopecia, back pain, bacterial vaginosis, bladder disorder, contusion, dysmenorrhoea, dyspareunia, fallopian tube perforation, fatigue, feeling abnormal, genital haemorrhage, headache, hypersensitivity, menorrhagia, migraine, nausea, pelvic pain, premature menopause, tooth disorder, urinary tract disorder, vaginal haemorrhage, visual impairment, vulvovaginal pain and weight increased to be related to essure.The reporter commented: essure device was placed in the ostia.One coils noted.Three and half coils noted beyond the ostia in the uterine cavity.Discrepancy noted in insertion date.Previously reported as: (b)(6) 2013.In current follow up reported as: (b)(6) 2013.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.8 kg/sqm.Hysterosalpingogram - on (b)(6) 2014: total bilateral occlusion.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: menorrhagia, pelvic pain, dyspareunia.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 30-oct-2018: quality safety evaluation of ptc.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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Spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("perforation (fallopian tube)") and genital haemorrhage ("heavy and persistent bleeding") in a 29-year-old female patient who had essure (batch no.A90480) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included body mass index normal and urinary frequency.Concomitant products included naproxen sodium (midol extended relief caplet).On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced premature menopause ("hormonal changes describe: early menopause"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia"), bacterial vaginosis ("bacterial vaginosis"), contusion ("rashes or skin conditions type: bruising"), bladder disorder ("bladder or urinary problems or changes"), urinary tract disorder ("bladder or urinary problems or changes"), migraine ("migraines"), headache ("headaches"), nausea ("nausea"), tooth disorder ("dental problems"), feeling abnormal ("neurological conditions or problems type: brain fog"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), visual impairment ("vision/eye problems type: vision is damaged"), fatigue ("fatigue"), weight increased ("weight gain"), vulvovaginal pain ("vaginal pain") and back pain ("lower back region").On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), abdominal pain ("severe abdominal cramping"), pelvic pain ("severe pelvic cramping/ chronic pelvic pain"), alopecia ("hair loss") and hypersensitivity ("allergic reactions").The patient was treated with surgery (salpingectomy (bilateral removal of fallopian tubes),).Essure was removed on (b)(6) 2017.At the time of the report, the fallopian tube perforation, genital haemorrhage, abdominal pain, hypersensitivity, premature menopause, vaginal haemorrhage, menorrhagia, bacterial vaginosis, contusion, bladder disorder, urinary tract disorder, migraine, headache, nausea, tooth disorder, dyspareunia, visual impairment, fatigue, weight increased and vulvovaginal pain outcome was unknown and the pelvic pain, alopecia, feeling abnormal, dysmenorrhoea and back pain was resolving.The reporter considered abdominal pain, alopecia, back pain, bacterial vaginosis, bladder disorder, contusion, dysmenorrhoea, dyspareunia, fallopian tube perforation, fatigue, feeling abnormal, genital haemorrhage, headache, hypersensitivity, menorrhagia, migraine, nausea, pelvic pain, premature menopause, tooth disorder, urinary tract disorder, vaginal haemorrhage, visual impairment, vulvovaginal pain and weight increased to be related to essure.The reporter commented: essure device was placed in the ostia.One coils noted.Three and half coils noted beyond the ostia in the uterine cavity.Discrepancy noted in insertion date.Previously reported as: (b)(6) 2013.In current follow up reported as: (b)(6) 2013.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.8 kg/sqm.Hysterosalpingogram - on (b)(6) 2014: total bilateral occlusion.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: menorrhagia, pelvic pain, dyspareunia.Quality-safety evaluation of ptc: no sample available for this investigation.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.The reported medical events are not necessarily indicative of a quality defect.As no batch number was reported a technical batch investigation and a review of similar ae case reports is not possible.No complaint sample was provided for further investigation therefore the complaint could not be evaluated in greater detail.The technical assessment concluded a quality defect was not confirmed but considered plausible.No specific quality issue was defined, therefore no meddra llt can be provided.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.Most recent follow-up information incorporated above includes: on 18-oct-2018: medical records- lot number was added.Incident at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental 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 ('embedded into my ovaries / migration in my ovaries'), fallopian tube perforation ('perforation (fallopian tube)'), embedded device ('embedded into my ovaries') and genital haemorrhage ('heavy and persistent bleeding') in a 29-year-old female patient who had essure (batch no.A90480) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included body mass index normal and urinary frequency.Concomitant products included naproxen sodium (midol extended relief caplet).On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced genital haemorrhage (seriousness criterion medically significant), pelvic pain ("severe pelvic cramping/ chronic pelvic pain"), alopecia ("hair loss"), premature menopause ("hormonal changes describe: early menopause"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia"), bacterial vaginosis ("bacterial vaginosis"), contusion ("rashes or skin conditions type: bruising"), bladder disorder ("bladder or urinary problems or changes"), urinary tract disorder ("bladder or urinary problems or changes"), migraine ("migraines"), headache ("headaches"), nausea ("nausea"), tooth disorder ("dental problems"), feeling abnormal ("neurological conditions or problems type: brain fog"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), visual impairment ("vision/eye problems type: vision is damaged"), fatigue ("fatigue"), vulvovaginal pain ("vaginal pain") and back pain ("lower back region") and was found to have weight increased ("weight gain").On (b)(6) 2017, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), 3 years 8 months after insertion of essure.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), abdominal pain ("severe abdominal cramping") and hypersensitivity ("allergic reactions").The patient was treated with metformin, phentermine and surgery (salpingectomy (bilateral removal of fallopian tubes),).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, fallopian tube perforation, embedded device, genital haemorrhage, abdominal pain, hypersensitivity, premature menopause, vaginal haemorrhage, menorrhagia, bacterial vaginosis, contusion, bladder disorder, urinary tract disorder, migraine, headache, nausea, tooth disorder, dyspareunia, visual impairment, fatigue, weight increased and vulvovaginal pain outcome was unknown and the pelvic pain, alopecia, feeling abnormal, dysmenorrhoea and back pain was resolving.The reporter considered abdominal pain, alopecia, back pain, bacterial vaginosis, bladder disorder, contusion, device dislocation, dysmenorrhoea, dyspareunia, embedded device, fallopian tube perforation, fatigue, feeling abnormal, genital haemorrhage, headache, hypersensitivity, menorrhagia, migraine, nausea, pelvic pain, premature menopause, tooth disorder, urinary tract disorder, vaginal haemorrhage, visual impairment, vulvovaginal pain and weight increased to be related to essure.The reporter commented: essure device was placed in the ostia.One coils noted.Three and half coils noted beyond the ostia in the uterine cavity.Discrepancy noted in insertion date.Previously reported as: (b)(6) 2013.In current follow up reported as: (b)(6) 2013.Removal helped tremendously.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.8 kg/sqm.Hysterosalpingogram - on (b)(6) 2014: results: total bilateral occlusion.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: menorrhagia, pelvic pain, dyspareunia, essure micro-insert dislocation and essure micro-insert embedded.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 2-dec-2019: social media received: new event (essure micro-insert embedded and essure micro-insert dislocation) and reporter added.Incident 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 non-conformances data; should any new and reportable information become available as a result, 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 ('embedded into my ovaries / migration in my ovaries'), fallopian tube perforation ('perforation (fallopian tube)') and embedded device ('embedded into my ovaries') in a 29-year-old female patient who had essure (batch no.A90480) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included body mass index normal and urinary frequency.Concomitant products included naproxen sodium (midol extended relief caplet).On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced genital haemorrhage ("heavy and persistent bleeding"), pelvic pain ("severe pelvic cramping/ chronic pelvic pain"), alopecia ("hair loss"), premature menopause ("hormonal changes describe: early menopause"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia"), bacterial vaginosis ("bacterial vaginosis"), contusion ("rashes or skin conditions type: bruising"), bladder disorder ("bladder or urinary problems or changes"), urinary tract disorder ("bladder or urinary problems or changes"), migraine ("migraines"), headache ("headaches"), nausea ("nausea"), tooth disorder ("dental problems"), feeling abnormal ("neurological conditions or problems type: brain fog"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), visual impairment ("vision/eye problems type: vision is damaged"), fatigue ("fatigue"), vulvovaginal pain ("vaginal pain") and back pain ("lower back region") and was found to have weight increased ("weight gain").On (b)(6) 2017, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), 3 years 8 months after insertion of essure.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), abdominal pain ("severe abdominal cramping"), hypersensitivity ("allergic reactions") and thyroid disorder ("thyroid problems").The patient was treated with metformin, phentermine and surgery (salpingectomy (bilateral removal of fallopian tubes),).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, fallopian tube perforation, embedded device, genital haemorrhage, abdominal pain, hypersensitivity, premature menopause, vaginal haemorrhage, menorrhagia, bacterial vaginosis, contusion, bladder disorder, urinary tract disorder, migraine, headache, nausea, tooth disorder, dyspareunia, visual impairment, fatigue, weight increased, vulvovaginal pain and thyroid disorder outcome was unknown and the pelvic pain, alopecia, feeling abnormal, dysmenorrhoea and back pain was resolving.The reporter considered abdominal pain, alopecia, back pain, bacterial vaginosis, bladder disorder, contusion, device dislocation, dysmenorrhoea, dyspareunia, embedded device, fallopian tube perforation, fatigue, feeling abnormal, genital haemorrhage, headache, hypersensitivity, menorrhagia, migraine, nausea, pelvic pain, premature menopause, thyroid disorder, tooth disorder, urinary tract disorder, vaginal haemorrhage, visual impairment, vulvovaginal pain and weight increased to be related to essure.The reporter commented: essure device was placed in the ostia.One coils noted.Three and half coils noted beyond the ostia in the uterine cavity.Discrepancy noted in insertion date.Previously reported as: (b)(6) 2013, in current follow up reported as: (b)(6) 2013.Removal helped tremendously.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.8 kg/sqm.Hysterosalpingogram - on (b)(6) 2014: results: total bilateral occlusion.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: menorrhagia, pelvic pain, dyspareunia, essure micro-insert dislocation and essure micro-insert embedded.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-mar-2020: social media received: event added- thyroid disorder.Reporter added.Event of genital haemorrhage downgraded to non-serious.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 ('embedded into my ovaries / migration in my ovaries'), fallopian tube perforation ('perforation (fallopian tube)') and embedded device ('embedded into my ovaries') in a 29-year-old female patient who had essure (batch no.A90480) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included body mass index normal and urinary frequency.Concomitant products included naproxen sodium (midol extended relief caplet).On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced genital haemorrhage ("heavy and persistent bleeding"), pelvic pain ("severe pelvic cramping/ chronic pelvic pain"), alopecia ("hair loss"), premature menopause ("hormonal changes describe: early menopause"), vaginal haemorrhage ("abnormal bleeding vaginal"), menorrhagia ("menorrhagia"), bacterial vaginosis ("bacterial vaginosis"), contusion ("rashes or skin conditions type: bruising"), bladder disorder ("bladder or urinary problems or changes"), urinary tract disorder ("bladder or urinary problems or changes"), migraine ("migraines"), headache ("headaches"), nausea ("nausea"), tooth disorder ("dental problems"), feeling abnormal ("neurological conditions or problems type: brain fog"), dysmenorrhoea ("dysmenorrhea cramping"), dyspareunia ("dyspareunia (painful sexual intercourse)"), visual impairment ("vision/eye problems type: vision is damaged"), fatigue ("fatigue"), vulvovaginal pain ("vaginal pain") and back pain ("lower back region") and was found to have weight increased ("weight gain").On (b)(6) 2017, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), 3 years 8 months after insertion of essure.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), abdominal pain ("severe abdominal cramping"), hypersensitivity ("allergic reactions") and thyroid disorder ("thyroid problems").The patient was treated with metformin, phentermine and surgery (salpingectomy bilateral removal of fallopian tubes).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, fallopian tube perforation, embedded device, genital haemorrhage, abdominal pain, hypersensitivity, premature menopause, vaginal haemorrhage, menorrhagia, bacterial vaginosis, contusion, bladder disorder, urinary tract disorder, migraine, headache, nausea, tooth disorder, dyspareunia, visual impairment, fatigue, weight increased, vulvovaginal pain and thyroid disorder outcome was unknown and the pelvic pain, alopecia, feeling abnormal, dysmenorrhoea and back pain was resolving.The reporter considered abdominal pain, alopecia, back pain, bacterial vaginosis, bladder disorder, contusion, device dislocation, dysmenorrhoea, dyspareunia, embedded device, fallopian tube perforation, fatigue, feeling abnormal, genital haemorrhage, headache, hypersensitivity, menorrhagia, migraine, nausea, pelvic pain, premature menopause, thyroid disorder, tooth disorder, urinary tract disorder, vaginal haemorrhage, visual impairment, vulvovaginal pain and weight increased to be related to essure.The reporter commented: essure device was placed in the ostia.One coils noted.Three and half coils noted beyond the ostia in the uterine cavity.Discrepancy noted in insertion date.Previously reported as: (b)(6) 2013.In current follow up reported as: 26aug2013.Removal helped tremendously.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.8 kg/sqm.Hysterosalpingogram - on (b)(6) 2014: results: total bilateral occlusion.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: menorrhagia, pelvic pain, dyspareunia, essure micro-insert dislocation and essure micro-insert embedded.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 30-apr-2020: quality safety evaluation of ptc (product technical complaint).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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