Model Number ESS305 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problem
Pain (1994)
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Event Type
Injury
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Event Description
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The below report was received by health authority ansm (reference number: (b)(4)) on 18-mar-2024.This spontaneous case was originally reported by a consumer and describes the occurrence of pelvic pain ("pelvic pain") in a 62 year-old female patient who had essure inserted for female sterilisation.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2014, 138 days after essure insertion, she experienced heavy menstrual bleeding ("haemorrhagic periods"), myalgia ("constant muscle pain"), fatigue ("significant chronic fatigue") and visual impairment ("sight disorder").On unknown date she experienced pelvic pain (seriousness criterion medically important).At the time of the report, the outcomes for these events were unknown.No causality assessment was received for essure with regard to heavy menstrual bleeding, myalgia, fatigue, pelvic pain or visual impairment.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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The below report was received by health authority ansm (reference number: (b)(4)) on 18-mar-2024.The most recent information was received on 26-mar-2024.This spontaneous case was originally reported by a consumer and describes the occurrence of pelvic pain ("pelvic pain") in a 62 year-old female patient who had essure inserted for permanent contraceptive tubal implant.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2014, 138 days after essure insertion, she experienced heavy menstrual bleeding ("haemorrhagic periods"), myalgia ("constant muscle pain"), fatigue ("significant chronic fatigue") and visual impairment ("sight disorder").On unknown date she experienced pelvic pain (seriousness criterion medically important).At the time of the report, the outcomes for these events were unknown.No causality assessment was received for essure with regard to heavy menstrual bleeding, myalgia, fatigue, pelvic pain or visual impairment.Quality-safety evaluation of ptc: for essure: 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.The most recent follow-up information incorporated above includes data received on: 26-mar-2024: quality safety evaluation of product technical complaint.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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Search Alerts/Recalls
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