This spontaneous case was reported by a healthcare professional and describes the occurrence of abdominal pain lower ("episodes of acute pain in the right iliac fossa unrelated to periods") in a 48 year-old female patient who had essure inserted.Additional non-serious events are detailed below.The patient had a medical history of atopic asthma, abdominal wall hematoma, caesarean section and body mass index normal.On (b)(6) 2016, the patient had essure inserted.Essure was removed on (b)(6) 2023.On unknown date she experienced abdominal pain lower (seriousness criterion intervention required) and intermenstrual bleeding ("metrorrhagia at the start of menstrual periods").The patient was treated with surgery (bilateral cornuectomy).At the time of the report, the outcomes for these events were unknown.The reporter considered abdominal pain lower and intermenstrual bleeding to be related to essure administration.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 23.833 kg/sqm.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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This spontaneous case was reported by a healthcare professional and describes the occurrence of abdominal pain lower ("episodes of acute pain in the right iliac fossa unrelated to periods") in a 48 year-old female patient who had essure inserted.Additional non-serious events are detailed below.The patient had a medical history of atopic asthma, abdominal wall haematoma, caesarean section and body mass index normal.On (b)(6) 2016, the patient had essure inserted.On unknown date she experienced abdominal pain lower (seriousness criterion intervention required) and intermenstrual bleeding ("metrorrhagia at the start of menstrual periods").The patient was treated with surgery (bilateral cornuectomy) and essure was removed on (b)(6) 2023.At the time of the report, the outcomes for these events were unknown.The reporter considered abdominal pain lower and intermenstrual bleeding to be related to essure administration.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 23.833 kg/sqm.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: 22-feb-2024: quality safety evaluation of ptc.21-feb-2024: health authority reference number added.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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