A definitive root cause is undetermined.The sample as received was stuck to the inside of the inner tyvek retainer.The mesh itself was inside of the retainer and had to be removed by slowly peeling back the retainer as the mesh is still extremely tacky from being hydrated.This caused the hydrogel material to stick to the retainer.Sutures were placed in the mesh during preparation for use, however, it is unknown if the sutures were placed prior to hydration.Due to the condition of the physical sample the photo provided by the customer was used for the evaluation.Evaluation of the photo provided confirms the reported event.The photo provided shows the hydrogel has separated as reported.Based on the available information and condition of the sample a definitive conclusion cannot be determined.It is likely that hydrogel may have been overhydrated and subsequent handling of the mesh inadvertently damaged the hydrogel barrier.No manufacturing anomalies were found.Per the instructions-for-use the "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 review of the manufacturing records was performed and found that the lot was manufactured to specification.To date this is the only reported complaint for this production lot of 167 units released for distribution in may, 2017.
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