Model Number ESS305 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Fatigue (1849); Headache (1880); Itching Sensation (1943); Pain (1994); Myalgia (2238); Arthralgia (2355); Sleep Dysfunction (2517)
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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 ((b)(6), (b)(4)) on 04-jun-2018.This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("pelvic pain") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), myalgia ("muscular pain"), arthralgia ("joint pain"), headache ("headaches"), insomnia ("loss of sleep"), fatigue ("significant fatigue"), dyspareunia ("dyspareunia"), pruritus ("itching with redness") and erythema ("itching with redness").The patient was treated with surgery (essure removal).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, myalgia, arthralgia, headache and insomnia had resolved, the fatigue was resolving and the dyspareunia, pruritus and erythema outcome was unknown.The reporter provided no causality assessment for arthralgia, dyspareunia, erythema, fatigue, headache, insomnia, myalgia, pelvic pain and pruritus 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 04-jun-2018 for the following meddra preferred term: pelvic pain.The analysis in the global safety database revealed 11462 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 04-jun-2018.The most recent information was received on 03-jul-2018.This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("pelvic pain") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), myalgia ("muscular pain"), arthralgia ("joint pain"), headache ("headaches"), insomnia ("loss of sleep"), fatigue ("significant fatigue"), dyspareunia ("dyspareunia"), pruritus ("itching with redness") and erythema ("itching with redness").The patient was treated with surgery (essure removal).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, myalgia, arthralgia, headache and insomnia had resolved, the fatigue was resolving and the dyspareunia, pruritus and erythema outcome was unknown.The reporter provided no causality assessment for arthralgia, dyspareunia, erythema, fatigue, headache, insomnia, myalgia, pelvic pain and pruritus 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: pelvic pain.The analysis in the global safety database revealed 11656 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 3-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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Search Alerts/Recalls
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