Other text: d4 and g5 are unknown.No product information has been provided to date.This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.No problems or issues were identified during this device history record review as a result of observation, a tear of 3 centimeters (cm) was confirmed.The results of the operation team survey are as follows.Only the barcode label was attached to this product, but since it was not subject to visual inspection, the detailed package has not been inspected.Regarding the packing form of this product, the box opens upward, and each box contains 10 pieces.Two pieces of four stations are staggered, and one piece of two stations was placed on top.The product package was handled in a connected state, it was unlikely that the operator's finger will touch the torn part, and the label affixing position and the torn part was parallel to each other, there was little possibility that pressure will be applied when the label was affixed.As a result of the above, the possibility of damage during label sticking work was extremely low.The reported event was confirmed.The root cause was possibility of package damage may have occurred after shipped or before it was received from the supplier.The information was shared with the operation team about the occurrence of this event and requested the supplier to investigate the eve.
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