Model Number ESS305 |
Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Headache (1880); Pain (1994); Myalgia (2238); Arthralgia (2355); Depression (2361); No Code Available (3191)
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Event Date 05/23/2018 |
Event Type
Injury
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Event Description
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This case was initially received via regulatory authority ((b)(6), reference number: (b)(6)) on (b)(6) 2018.This spontaneous case was reported by an other health professional and describes the occurrence of medical device removal ("patient wishing the removal of essure") and endometriosis ("two nodules of endometriosis (douglas pouch, left lateral wall)") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included sarcoidosis.On (b)(6) 2016, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required), endometriosis (seriousness criterion medically significant), arthralgia ("joint pain"), myalgia ("muscle pain"), depression ("depression"), asthenia ("asthenia") and migraine ("migraine").The patient was treated with surgery (essure removed on patient's wish) and surgery (two nodules of endometriosis (douglas pouch, left lateral wall) removed on (b)(6) 2018).Essure was removed on (b)(6) 2018.At the time of the report, the medical device removal, endometriosis, arthralgia, myalgia, depression, asthenia and migraine outcome was unknown.The reporter provided no causality assessment for arthralgia, asthenia, depression, endometriosis, medical device removal, migraine and myalgia with essure.The reporter commented: patient wishing the removal of essure causing migraine, joint pain, asthenia, depression and muscle pain.On (b)(6) 2018, intact uterine tubes, no breaking of implants, two nodules of endometriosis (douglas pouch, left lateral wall) and essure removed.Diagnostic results: laparoscopy - on (b)(6) 2018: intact uterine tubes, no breaking of implants, two nodules of endometriosis (douglas pouch, left lateral wall) and essure removed.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same meddra preferred term.In this particular case a search in the database was performed on (b)(6) 2018 for the following meddra preferred term: medical device removal - the analysis in the global safety database revealed 758 cases bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.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 case was initially received via regulatory authority (ansm, reference number: (b)(4)) on 04-jun-2018.The most recent information was received on 04-jul-2018.This spontaneous case was reported by an other health professional and describes the occurrence of medical device removal ("patient wishing the removal of essure") and endometriosis ("two nodules of endometriosis (douglas pouch, left lateral wall)") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included sarcoidosis.On (b)(6) 2016, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required), endometriosis (seriousness criterion medically significant), arthralgia ("joint pain"), myalgia ("muscle pain"), depression ("depression"), asthenia ("asthenia") and migraine ("migraine").The patient was treated with surgery (essure removed on patient's wish) and surgery (two nodules of endometriosis (douglas pouch, left lateral wall) removed on (b)(6) 2018).Essure was removed on (b)(6) 2018.At the time of the report, the medical device removal, endometriosis, arthralgia, myalgia, depression, asthenia and migraine outcome was unknown.The reporter provided no causality assessment for arthralgia, asthenia, depression, endometriosis, medical device removal, migraine and myalgia with essure.The reporter commented: patient wishing the removal of essure causing migraine, joint pain, asthenia, depression and muscle pain.On (b)(6) 2018, intact uterine tubes, no breaking of implants, two nodules of endometriosis (douglas pouch, left lateral wall) and essure removed.Diagnostic results: laparoscopy - on (b)(6) 2018: intact uterine tubes, no breaking of implants, two nodules of endometriosis (douglas pouch, left lateral wall) and essure removed.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same meddra preferred term.In this particular case a search in the database was performed on (b)(6) 2018 for the following meddra preferred term: medical device removal - the analysis in the global safety database revealed 858 cases bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 4-jul-2018: quality-safety evaluation of ptc.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 case was initially received via regulatory authority (ansm, reference number: r1809124) on (b)(6)2018.The most recent information was received on (b)(6)2018.This spontaneous case was reported by an other health professional and describes the occurrence of medical device removal ("essure removed upon patient's request, by total bilateral salpingectomy via coelioscopy/ device removal") and endometriosis ("two nodules of endometriosis (douglas pouch, left lateral wall)") in a 44-year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included sarcoidosis.On (b)(6)-2016, the patient had essure inserted.On (b)(6)2018, 2 years 2 months after insertion of essure, the patient underwent medical device removal (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced endometriosis (seriousness criterion medically significant), arthralgia ("joint pain"), myalgia ("muscle pain"), depression ("depression"), asthenia ("asthenia") and migraine ("migraine").The patient was treated with surgery (total bilateral salpingectomy via coelioscopy) and surgery (two nodules of endometriosis (douglas pouch, left lateral wall) removed on (b)(6)2018).Essure was removed on (b)(6)2018.At the time of the report, the medical device removal, endometriosis, arthralgia, myalgia, depression, asthenia and migraine outcome was unknown.The reporter provided no causality assessment for arthralgia, asthenia, depression, endometriosis, medical device removal, migraine and myalgia with essure.The reporter commented: patient reported that essure was causing migraine, joint pain, asthenia, depression and muscle pain.On (b)(6)2018, intact uterine tubes, no breaking of implants, two nodules of endometriosis (douglas pouch, left lateral wall) and essure removed.As per follow-up of (b)(6)2018: essure was removed at patient's request.Diagnostic results: laparoscopy - on(b)(6)2018: intact uterine tubes, no breaking of implants, two nodules of endometriosis (douglas pouch, left lateral wall) and essure removed.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6)2018: follow up (removal questionnaire) received.This case refers to 44-year-old female patient.Her details were updated, and it was informed that the essure removed on (b)(6)-2018 upon patient's request, by total bilateral salpingectomy via coelioscopy.No further data expected.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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Search Alerts/Recalls
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