Patient identifier - requested, not provided.Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Lot number - requested, not provided.Expiration date - unknown due to unknown lot number.Udi - unknown due to unknown lot number.Explanted date: device was not explanted.Device manufacture date - unknown due to unknown lot number.The actual device was not returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record of the product code/lot# combination was conducted with no findings.
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This report is being submitted as follow up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.With no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.
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