The sample evaluation confirms that a section of the hydrogel coating separated creating a void as reported.The returned sample had been sized / trimmed by the user and there is a finger / thumb print present in the hydrogel coating from handling.While handling the device a portion of the hydrogel in the area of the separation came in contact with fluid and hydrated.The separation of the hydrogel coating is consistent with hydrated hydrogel coming in contact with the dry portion of the hydrogel.This caused the coating to stick and peel up causing the separation found.This complaint is confirmed for user interface.No malfunction of the device was found.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 manufacturing lot of 202 units released for distribution in march, 2018.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.
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It was reported that on (b)(6) 2018 while preparing a davol ventralight st mesh for use it was noted that, "it appears a small part of the (hydrogel) barrier has been compromised and you can see through it." the mesh was not implanted.A second piece of davol ventralight st mesh was used to complete the case without issue.As reported the problem resulted in an inconsequential delay, there was no impact to the patient.
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