Model Number ESS305 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Autoimmune Disorder (1732); Headache (1880); Pain (1994)
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Event Type
Injury
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Event Description
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("chronic pelvic pain") and autoimmune disorder ("autoimmune symptoms") in a female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), autoimmune disorder (seriousness criterion medically significant) and migraine ("migraines").The patient was treated with surgery (surgical removal of the device).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, autoimmune disorder and migraine outcome was unknown.The reporter considered autoimmune disorder, migraine and pelvic pain to be related to essure.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 spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("chronic pelvic pain") and autoimmune disorder ("autoimmune symptoms") in a female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), autoimmune disorder (seriousness criterion medically significant) and migraine ("migraines").The patient was treated with surgery (surgical removal of the device).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, autoimmune disorder and migraine outcome was unknown.The reporter considered autoimmune disorder, migraine and pelvic pain to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 2-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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