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.627734).There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2008, the patient had essure inserted.An unknown time later she underwent medical device removal (seriousness criterion intervention required).The reporter considered medical device removal to be related to essure administration.Lot number:627734 manufacturing date: 2008-07 expiration date: 2010-07.Quality-safety evaluation of ptc: for essure: unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: 07-jul-2022: the adverse event injury nos was changed to medical device removal and patient´s initials updated.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 non-conformances data; should any new and reportable information become available as a result, 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 ("the foreign-body material has been removed") in a female patient who had essure inserted (lot no.627734).There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2008, the patient had essure inserted.An unknown time later she underwent medical device removal (seriousness criteria medically important and intervention required).The reporter considered medical device removal to be related to essure administration.Lot number:627734 manufacturing date: 2008-07 expiration date: 2010-07.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: 13-jul-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 non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.
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