Udi: (b)(4).Applicable device history record (dhr)s were reviewed and no discrepancies were found.The sample was not returned thus evaluation is being completed based on provided photo.Pattie was reported to have a large brown contamination on the pattie despite still being sealed.This brown spot is consistent with a pattie burn.The spot was produced when the string was welded to the cottonoid material.The cottonoid is formed from a rayon material.During processing, this rayon material is broken down into small, loose fibers.If the fibers are not broken down properly, a small cluster of fibers will result causing a thick spot in the pattie.When the string is ultrasonically welded on this spot it absorbs more energy than the rest of the pattie and resulting in a burn.Automated machines are used to produce this product code.The patties are inspected by a computer vision inspection system that inspects the patties for defects.The burn marks are difficult to detect due to the type of color filters used on the camera lens.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.
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