A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Three pictures were received and evaluated.The pictures provided confirm that the product inside the box is not what the label on the box specifies.The technician was unable to confirm the lot number received by the customer.Another complaint with the same issue and the same sku and lot # was generated for investigation.It is suspected that the boxes for both lots were pre-assembled and pre-labeled at about the same time.The wrong labels were applied to the shipper box.A non-conformance report (ncr) was initiated for further investigation.Operator of device and initial are unknown.No product information has been provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).
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