Pc-(b)(4).Date sent to the fda: (b)(4) 2018.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.An opened box, an empty opened foil and an opened folder with an oxidized regenerated cellulose (orc) layer and a mesh of product code (b)(4), lot # lbg077 were returned for analysis.During the visual inspection of the sample, mesh and orc layer were noted totally separated.The orc layer present body fluids and it had rolled up into a folded position and separated from the psm layer.In addition, the body fluids on the orc layer and mesh are indications of lack of sufficient stoppage of bleeding.Any contact of mesh device with liquids such as blood, or soaking in saline or other antiseptic solutions, increases the likelihood of delamination.Exposure time during contact with blood prior to completion of secured mesh placement, could contribute to separation of orc layer of mesh.The foil was reviewed and the external appearance did not present damage or defects.Seal margin was continued and no defect or damage were observed that indicate a possibility of loss of integrity.Due to the condition of the sample received, it could not be determined what may have caused the reported incident.
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