The device was investigated, and the reported tear, rip or hole in the device packaging was not confirmed.The corner of the shelf carton was however, observed to be damaged.Additionally, the color on the label on the shelf carton was noted to be faded.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no other complaints reported from this lot.All available information was investigated, and a cause for the reported packaging tears, rips and holes/observed damage to the shelf carton (product quality problem) and the faded color on the label on the shelf carton (device markings/labelling problem) cannot be determined.There is no indication of a product issue with respect to manufacture, design or labeling.Na.
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