No product was returned for inspection.Without the returned product, there is not enough evidence to form a conclusion on the reported event.Therefore, based on the available information, device malfunction and the reported event could not be verified without the product returned as the dhr and complaint history did not indicate any device issues.Dhr review was completed for the subject lot number.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.A device history review was performed and no related nonconformance¿s were noted.Also a complaint history search was performed using our complaint handling system and there were no additional related complaints for this product lot.A root cause cannot be determined.The following sections have been updated: expiration date, udi: (b)(4).
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