Plant investigation: complaint sample is not available, and the lot number of product involved in this event i sunk.However, a three month sales and shipping search to the client site demonstrated that (b)(4) production lots have been shipped to the site.According to the sap system no product is available from these lots in distribution centers to be analyzed.The entire lots have been sold and distributed.Dhr review was performed on potential related lots.On nonconformance reports or other abnormalities during the assembly of these lots were found.The product involved met current specs.A search was conducted in pilgrim complaints system, and no other complaints with the same symptom code were found for any of the potential related lots.Medical records info reviewed.This event has been reported as a serious injury, although it is undetermined if there is a reasonable suspected causal relationship between the product(s) and the event.There is no history of specific malfunction or product being out of specs.The allegations of serious injury remain speculative in nature.The event reported on the pt involves four separate products and associated with mdrs #1225714-2014-00479, 00480, 1713747-2014-00296.
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