This spontaneous case was reported by a lawyer and describes the occurrence of medical device removal ("hysterectomy") and autoimmune thyroiditis ("hashimotos disease") in a female patient who had essure inserted.On an unknown date, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required) and autoimmune thyroiditis (seriousness criterion medically significant).Essure was removed.At the time of the report, the medical device removal and autoimmune thyroiditis outcome was unknown.The reporter considered autoimmune thyroiditis and medical device removal to be related to essure.Concerning the injuries reported in this case, the following one/ones were described in patient¿s social media post :autoimmune thyroiditis and medical device removal.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.
|
This spontaneous case was reported by a lawyer and describes the occurrence of medical device removal ("hysterectomy") and autoimmune thyroiditis ("hashimotos disease") in a female patient who had essure inserted.On an unknown date, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required) and autoimmune thyroiditis (seriousness criterion medically significant).The patient was treated with surgery (medical device removal).Essure was removed.At the time of the report, the medical device removal and autoimmune thyroiditis outcome was unknown.The reporter considered autoimmune thyroiditis and medical device removal to be related to essure.Concerning the injuries reported in this case, the following one/ones were described in patient¿s social media post: autoimmune thyroiditis and medical device removal.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 1-nov-2018: quality safety evaluation of ptc (product technical complaint).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.
|