Medtronic complaint number: (b)(4).Evaluation of the device was based on a technical review of all data received from the site, a review of complaint trends and an evaluation of the returned device.The visual examination of the returned sample showed that the mesh was folded and some parts were stuck to the collagen face.The collagen film was incomplete, and the shape of the mesh was modified by a round cut on the white side.Based on the visual examination: the sample was manipulated by the user.The root cause could not be determined.Should new information become available, the file will be opened and the investigation summary amended as appropriate.If information is provided in the future, a supplemental report will be issued.
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