Evaluation summary: no data regarding product identity was received, i.E.No lot or serial number were indicated for the event; therefore, the device history record (dhr) could not be reviewed.There was no sample returned; therefore, the condition of the product could not be verified.All products pass 100% final inspection at the manufacturer prior to approval.If a defect would be noticed, the product would have been rejected immediately.The root cause could not be determined.The manufacturer internal reference number is: (b)(4).
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