The information provided regarding this event is limited, the contact reports being unable to provide any additional details.The sample was received manipulated for use as reported.The evaluation confirms for separation of the hydrogel barrier.The separation of the hydrogel observed is consistent with the hydrogel not being completely hydrated prior to rolling and insertion.The information provided is limited and it is unknown if the mesh was hydrated in preparation for the procedure.However, if only a portion of the mesh is hydrated and comes in contact with a dehydrated portion, the side that is hydrated is known to stick to the dry portion of the mesh.Based on the available information and product evaluation a definitive conclusion cannot be made.The instructions for use, supplied with the device state, 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.A minimum sized trocar is recommended for the laparoscopic delivery of ventralight ¿ st mesh.Insert the prosthesis through the trocar using a rigid instrument, such as non-serrated, 5 mm forceps; do not over force the prosthesis through trocar.If ventralight ¿ st mesh is hydrated longer than 3 seconds and/or does not easily deploy down the trocar, replace trocar and retry with the next available larger sized trocar.To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in may, 2017.
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