Model Number ESS305 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fatigue (1849); Headache (1880); Myalgia (2238); Depression (2361); Disability (2371)
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Event Type
Injury
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Event Description
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This case was initially received via regulatory authority (ansm, reference number: (b)(4)) on (b)(6) 2018.This spontaneous case was reported by a consumer and describes the occurrence of impaired work ability ("patient recognized as disable worker") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2011, the patient had essure inserted.On (b)(6) 2012, 2 months 14 days after insertion of essure, the patient experienced migraine ("migraines"), depression ("depression"), musculoskeletal pain ("joint and muscle pain") and fatigue ("fatigue").On an unknown date, the patient experienced impaired work ability (seriousness criterion disability).At the time of the report, the impaired work ability, migraine, depression, musculoskeletal pain and fatigue outcome was unknown.The reporter provided no causality assessment for depression, fatigue, impaired work ability, migraine and musculoskeletal pain with essure.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on (b)(6) 2018 for the following meddra preferred term: impaired work ability.The analysis in the global safety database revealed 3 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.Further company follow-up with the regulatory authority is not possible.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 (b)(6) 2018.The most recent information was received on (b)(6) 2018.This spontaneous case was reported by a consumer and describes the occurrence of impaired work ability ("patient recognized as disable worker") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2011, the patient had essure inserted.On (b)(6) 2012, 2 months 14 days after insertion of essure, the patient experienced migraine ("migraines"), depression ("depression"), musculoskeletal pain ("joint and muscle pain") and fatigue ("fatigue").On an unknown date, the patient experienced impaired work ability (seriousness criterion disability).At the time of the report, the impaired work ability, migraine, depression, musculoskeletal pain and fatigue outcome was unknown.The reporter provided no causality assessment for depression, fatigue, impaired work ability, migraine and musculoskeletal pain with essure.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on (b)(6) 2018 for the following meddra preferred term: impaired work ability.The analysis in the global safety database revealed 3 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 further company follow-up with the regulatory authority is not possible.Most recent follow-up information incorporated above includes: on (b)(6) 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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Search Alerts/Recalls
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