Model Number ESS305 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); No Code Available (3191)
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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 medical device removal ('removal') in an adult female patient who had essure inserted for female sterilisation.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required).The patient was treated with surgery (surgery to remove essure).Essure was removed on (b)(6) 2016.At the time of the report, the medical device removal outcome was unknown.The reporter considered medical device removal to be related to essure.Quality-safety evaluation of ptc: unable to confirm 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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of medical device removal ('removal') in an adult female patient who had essure inserted for female sterilisation.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required).The patient was treated with surgery (surgery to remove essure and oophorectomy).Essure was removed on (b)(6) 2016.At the time of the report, the medical device removal outcome was unknown.The reporter considered medical device removal to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 13-jul-2020: 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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain') in an adult female patient who had essure inserted for female sterilisation.The patient's medical history included low back pain, cesarean section and adhesion.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).The patient was treated with surgery (laparoscopic-assisted vaginal hysterectomy and bilateral salpingectomies).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain outcome was unknown.The reporter considered pelvic pain to be related to essure.The reporter commented: the tube was then cannulised with the essure device, releasing the essure, with 4 to 5 coils bei.Ng seen.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 5-mar-2021: mr received:" previously reported event medical device removal replaced with pelvic pain" reporter, medical history and rcc 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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Search Alerts/Recalls
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