This spontaneous case was originally reported by a lawyer on behalf of a consumer and describes the occurrence of medical device removal ("foreign body material has been removed") in a female patient who had essure (ess205) inserted (lot no.508905).Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.In (b)(6) 2006, the patient had essure (ess205) inserted.An unknown time later she experienced injury ("injury person") and underwent medical device removal (seriousness criterion intervention required).The patient was treated with surgery (essure removal).At the time of the report, the outcomes for these events were unknown.The reporter considered injury and medical device removal to be related to essure (ess205) administration.The reporter commented: various physical symptoms developed after this treatment.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.Lot number: 508905 manufacturing date:2005-10 expiration date: 2007-09.Quality-safety evaluation of ptc: for essure (ess205): unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: 10-aug-2022: previously reported event injury was updated to medical device removal; case upgraded to serious incident; reporter's information and patient's initial updated; essure model changed to ess205 (from ess305) and insertion date changed to (b)(6) 2006 (from (b)(6) 2006).We received a lot number in this case.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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This spontaneous case was originally reported by a lawyer on behalf of a consumer and describes the occurrence of medical device removal ("foreign body material has been removed") in a female patient who had essure (ess205) inserted (lot no.508905).There was no information on the patient's medical history or concurrent conditions.In (b)(6) 2006, the patient had essure (ess205) 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 (ess205) administration.The reporter commented: various physical symptoms developed after this treatment.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.Lot number: 508905, manufacturing date: 2005-10 and expiration date: 2007-09.Quality-safety evaluation of ptc: for essure (ess205): 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: 17-aug-2022: quality safety evaluation of ptc.We received a lot number in this case.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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