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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This case was initially received via regulatory authority ((b)(6), reference number: (b)(4)) on 17-mar-2021.This spontaneous case was reported by a consumer and describes the occurrence of iron deficiency anaemia ('iron deficiency anaemia') in an adult female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced iron deficiency anaemia (seriousness criteria medically significant and intervention required), fatigue ("chronic fatigue / exhaustion"), migraine ("very frequent migraines") and disturbance in attention ("loss of concentration").The patient was treated with iron infusions.At the time of the report, the iron deficiency anaemia, fatigue and migraine had not resolved and the disturbance in attention outcome was unknown.The reporter provided no causality assessment for disturbance in attention, fatigue, iron deficiency anaemia and migraine with essure.The reporter commented: progressive deterioration of health 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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This case was initially received via regulatory authority (ansm, reference number: (b)(4)) on 17-mar-2021.The most recent information was received on 25-mar-2021.This spontaneous case was reported by a consumer and describes the occurrence of iron deficiency anaemia ('iron deficiency anaemia') in an adult female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced iron deficiency anaemia (seriousness criteria medically significant and intervention required), fatigue ("chronic fatigue / exhaustion"), migraine ("very frequent migraines") and disturbance in attention ("loss of concentration").The patient was treated with iron infusions.At the time of the report, the iron deficiency anaemia, fatigue and migraine had not resolved and the disturbance in attention outcome was unknown.The reporter provided no causality assessment for disturbance in attention, fatigue, iron deficiency anaemia and migraine with essure.The reporter commented: progressive deterioration of health.Quality-safety evaluation of ptc: 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.Most recent follow-up information incorporated above includes: on 25-mar-2021: quality safety evaluation of ptc.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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