On (b)(6) 2018 device history record evaluation conducted.Batch record indicates no deviations from established acceptance criteria.Dimension specification were within acceptance criteria (length over 180 mm and nominal width of 53 mm).A review of lot retains for dimension similarly were within specification.No other similar complaints received on this lot.Possible cause was incomplete rolling down of the condom by consumer which could cause constriction but no definite root cause could be established.No further actions taken.
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