Model Number ESS305 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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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 originally reported by a lawyer on behalf of a consumer and describes the occurrence of medical device removal ("the foreign-body material has been removed.") in a female patient who had essure inserted (lot no.C12710).There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2015, the patient had essure inserted.An unknown time later she underwent medical device removal (seriousness criterion intervention required).The patient was treated with surgery (essure removal).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: discrepant information: in argus, essure's start date was (b)(6) 2015 but in this fu cycle was reported as (b)(6) 2015.Batch no c12710 production date 2014-01-15 expiration date 2017-01-31.Quality-safety evaluation of ptc: for essure: unable to confirm complaint the most recent follow-up information incorporated above includes data received on: 23-aug-2022: primary reporter's information and action taken with drug added, essure's start date updated from ''(b)(6) 2015'' to ''(b)(6) 2015'', device removal updated from ''no/unknown/not reported'' to ''yes'', adverse event ''injury nos'' was clarified as ''medical device removal'', listedness updated from ''unlisted'' to ''listed'', company causality assesment updated from ''unrelated'' to ''related'', current location of the device updated from ''remains implanted'' to ''unknown''.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was originally reported by a lawyer, on behalf of a consumer and describes the occurrence of medical device removal ("the foreign-body material has been removed").In a female patient who had essure inserted (lot no.C12710).There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2015, the patient had essure inserted.An unknown time later, she underwent medical device removal (seriousness criterion intervention required).The patient was treated with surgery (essure removal).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: discrepant information: in argus, essure's start date was (b)(6) 2015, but in this fu cycle was reported as (b)(6) 2015.Batch no: c12710, production date: 2014-01-15, expiration date: 2017-01-31.Quality safety evaluation of ptc: for essure: no defect could be confirmed, by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations, during the manufacturing process that could have caused the described complaint reason.Trend analyses of complaints are reviewed regularly, no signal was observed, with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample could not be conducted, as no sample was available.The most recent follow-up information incorporated above includes data received on: 29-aug-2022, quality safety evaluation of product technical complaint.A technical investigation was conducted.Including a batch review, and a review of complaint records and other relevant data.Should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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Search Alerts/Recalls
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