The information provided is limited and the sample has not been returned.
Requests for additional information, including sample return status have been made.
Based on the information provided, and not having the sample to evaluated no conclusion can be made.
It is unclear at this time what is meant by "the mesh began to fall apart" during attempted placement.
However, typically this would indicate that the mesh was over or under hydrated causing an issue with the hydrogel (st) coating.
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 (b)(4) units released for distribution in october, 2019.
Should additional information be provided or if the sample is returned for evaluation, a supplemental emdr will be submitted.
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It was reported that "when the o.
R.
Staff attempted to place the bard ventralight st mesh inside the patient, the mesh began to fall apart.
They were unable to continue using this particular mesh.
The procedure was able to be completed using other mesh the surgery unit had on hand.
" as reported, there was no patient injury.
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