The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If information is provided in the future, a supplemental report will be issued.
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No sample received.A device history record was reviewed and was confirmed that products were produced accomplishing quality requirements.The sample was not provided for evaluation and the reported condition could not been confirmed.The root cause and corrective actions could not be identified.This complaint will be closed with no further action; if sample is received later on, the complaint will be reopened for investigation.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.
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