Continuation of concomitant products: anufacturer).(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device or a picture of the alleged defect was not provided at the time of this report.A device history record review could not be conducted since the lot number was not provided.It is necessary the physical sample in order to perform a proper and thorough investigation.Customer complaint cannot be confirmed based on the information received.Root cause cannot be determined.No corrective actions can be established at this time.If the sample becomes available this report will be updated with the evaluation results.
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