(b)(4).
The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.
The following information was requested but unavailable: it was reported that an issue with the mesh was noted when the surgical staff opened the product during a hernia repair.
Please provide the following: did the mesh fall apart upon removal of device from the package, was the mesh discolored, did the mesh tear during implantation? did the device come in contact with the patient prior to it being removed from the surgical field after opening the package? how was the procedure completed? confirm that there were no patient consequences? a ventral patch in opened folder and one empty opened foil of product code pvpm, lot kl8bwmb0 were returned for analysis.
During visual inspection of the sample, body fluids on the ventral patch was noted; also, the two wings were partially detached.
In addition, there are several fragments of the pds base plate present, indicating significant degradation.
The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.
Due to the condition of the sample, no conclusion could be reached as to what may have caused the reported incident.
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