Model Number ESS305 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Type
Injury
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Event Description
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This spontaneous case was reported by a consumer and describes the occurrence of medical device removal ("foreign-body material has been removed") in a female patient who had essure inserted for female sterilisation.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2014, the patient had essure inserted.On unknown date she underwent medical device removal (seriousness criterion intervention required).The patient was treated with surgery (to remove essure).At the time of the report, the outcome of the event was unknown.The reporter considered medical device removal to be related to essure administration.The reporter commented: after this treatment, various physical symptoms developed.Since then, i have had follow-up treatments and the foreign-body material has been removed.As a result of the symptoms, i am hindered in my normal daily functioning, and i suffer damages.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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Manufacturer Narrative
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This spontaneous case was reported by a consumer and describes the occurrence of medical device removal ("foreign-body material has been removed") in a female patient who had essure inserted for female sterilization.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2014, the patient had essure inserted.On unknown date she underwent medical device removal (seriousness criterion intervention required).The patient was treated with surgery (to remove essure).At the time of the report, the outcome of the event was unknown.The reporter considered medical device removal to be related to essure administration.The reporter commented: after this treatment, various physical symptoms developed.Since then, i have had follow-up treatments and the foreign-body material has been removed.As a result of the symptoms, i am hindered in my normal daily functioning, and i suffer damages.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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