The returned device was removed from the shipping box and inspected.Upon inspection the pouch appeared to have been opened from the side of the sealed pouch and the pouch was ripped into the middle of the pouch.The pouch was attempted to be opened from the top of the package and it opened properly and without issue.The mesh was still inside the pouch with the protective film still covering the mesh.There were no signs of particulate on the protective film or upon the underlying mesh.It is not known how or why the mesh pouch was torn in such a manner.The details indicated that the adhesive was defective.A review of the adhesive bond showed no defects.A review of the device history records indicates that this lot of mesh passed all quality and performance requirements.A review of the complaint history shows that there have been no other complaints for this lot of mesh in regards to the packaging opening improperly.Summary/conclusion: based on the details of the complaint, atrium medical cannot conclude that the mesh packaging was faulty.
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