The information provided is limited and the sample was not returned for evaluation, as such no conclusion can be made.A review of the manufacturing records was performed and found that the lot was manufactured to specification.As reported the mesh was hydrated prior to insertion into a 12mm trocar.Specific details regarding the hydration of the mesh were not provided.As the hydrogel separation was not reported as an out of the box condition, it is possible that the alleged damage occurred during preparation.Based on the available information it is unknown if the user followed the proper hydration technique as prescribed in the instructions-for-use.It is known, that if portions of the hydrogel barrier do not get completely hydrated, when the product is rolled for insertion the dry portions will come in contact with hydrated portions causing the hydrogel barrier to stick to itself and peel off of the mesh.Note: the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Facility discarded.
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