The customer did not retain the product lot information.Therefore, the device history records traceable to the reported procedure pack could not be reviewed.A sample was not received to date, for this complaint report.Therefore, visual inspection or functional testing could not be conducted.Without a sample, it cannot be determined, if there were any physical anomalies that led to the customer's experience.The root cause of the customer's complaint could not be established, as a sample has not been received.Without a sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.No action will be taken for this occurrence, as the root cause is unknown.And a sample was not returned.Quality assurance will continue to monitor customer complaints via the complaint review meetings.And will take action for any future occurrences as is deemed necessary.The manufacturer internal reference number is: (b)(4).
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