This spontaneous case was reported by a lawyer and describes the occurrence of medical device removal ('removal') in a 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) 2018.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.
|
This spontaneous case was reported by a lawyer and describes the occurrence of medical device removal ('removal') in a 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) 2018.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.
|