As reported, during the preparation for use of the ventralight st mesh, the user noted a gel-like ¿foreign material¿ on the mesh.Subsequent information received, indicates that the reported "foreign material" is possibly referring to the st gel coating of the mesh.The tacky condition of the returned sample for evaluation is consistent with the mesh having been hydrated, also four sutures had been attached to the returned mesh by the user.In addition, the hydrated mesh was received folded in half with the st coating inwards.A visual examination of the returned sample did not identify any foreign matter on the sample.Some hydrogel st coating was noted to be separated from the mesh.Separation of the st coating is not unexpected based on the hydrated tacky mesh being folded upon itself during transit of the sample return.However, based on the as reported event it appears at least some of the st coating separation occurred during handling of the mesh directly following hydration.Details regarding the users method of preparing and hydrating the mesh have not been provided by the reporter.Per the instructions-for-use (ifu) ventralight¿ st mesh should be hydrated for no more than 1-3 seconds just prior to laparoscopic placement.If sutures are being placed, attach the sutures to the ventralight¿ st mesh before hydration.The prosthesis must be rolled immediately after hydration about its long axis (lengthwise) with the bioresorbable coating inside to protect the bioresorbable coating.Review of manufacturing records provided no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in september 2020.
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It was reported that immediately after opening the bard/davol ventralight st when attaching the needle thread to the mesh, it was noticed that a gel-like foreign material was attached.It was reported that another device was used to complete procedure.There was no reported patient injury.Subsequent information received, indicates that the reported "foreign material" is possibly referring to the st gel coating of the mesh.
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