Model Number ESS305 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Anemia (1706)
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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 26-oct-2023.This spontaneous case was originally reported by a consumer and describes the occurrence of blood loss anaemia ("anaemia") in an adult female patient who had essure inserted (lot no.E36574).Additional non-serious events are detailed below.As concurrent condition the report mentioned obesity.On (b)(6) 2016, the patient had essure inserted.An unknown time later she experienced blood loss anaemia (seriousness criterion medically important), myalgia ("muscular pain"), fatigue ("fatigue") and depression ("depression").Essure treatment was not changed.No causality assessment was received for essure with regard to myalgia, fatigue, blood loss anaemia or depression.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 125 kg.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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The below report was received by health authority ansm (reference number: (b)(4)) on 26-oct-2023.The most recent information was received on 22-dec-2023.This spontaneous case was originally reported by a consumer and describes the occurrence of blood loss anaemia ("anaemia") in an adult female patient who had essure inserted (lot no.E36574).Additional non-serious events are detailed below.As concurrent condition the report mentioned obesity.On (b)(6) 2016, the patient had essure inserted.An unknown time later she experienced blood loss anaemia (seriousness criterion medically important), myalgia ("muscular pain"), fatigue ("fatigue") and depression ("depression").Essure treatment was not changed.No causality assessment was received for essure with regard to myalgia, fatigue, blood loss anaemia or depression.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 125 kg.Lot number: e36574.Udi: (b)(4).Manufacturing date: 2015.10.Expiration date: 2018.10.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.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 could not be conducted, as no sample was available.The most recent follow-up information incorporated above includes data received on: 22-dec-2023: quality safety evaluation of ptc.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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Search Alerts/Recalls
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