(b)(4).The sample was returned for evaluation.A visual inspection was performed to determine if the sample had sustained any abuse/misuse/ damage.The cushion of the face mask was completely deflated due to a severe crack in the face mask itself.Based on the investigation performed, the reported complaint was confirmed.It is apparent from the visual inspection that the face mask was subjected to some kind of force great enough to crack the hard plastic, which in turn caused the leakage.This defect appears as though it could be the result of improper storage, mishandling, or abuse; although this could not be confirmed.There is no evidence that points to a manufacturing/assembly process issue.
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