This report is being submitted as part of a system level review: plant investigation: complaint sample is not available, and the lot number of product involved in this incident is unknown.However, a three month sales and shipping search to the client site demonstrated 7 lots.According to the sap system no product is available from these lots on distribution centers to be analyzed.The entire lots have been sold and distributed.Device history records review was performed on potential related lots.No nonconformance reports or other abnormalities during the assembly of these lots were found.The product involved met current specifications.A search was conducted in pilgrim complaints system, no add'l 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 specifications.The allegations of serious injury remain speculative in nature.The event reported on this patient involves six separate products and associated with mdr's 2937457-2014-01145, 1713747-2014-00315, 2937457-2014-00499, 1225714-2014-00513, 1225714-2014-00514, and 1713747-2014-99980.
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