(b)(4).Batch # unk.Date of event is unknown.Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our quality process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.If the product or additional information is received at a later date, the investigation will be updated as applicable.An evaluation of the manufacturing documentation could not be completed as the lot number was not provided.
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