Date of event: requested, not provided, lot number: requested, not provided, expiration date - unknown due to unknown lot number, udi - not required for product code, implanted date: device was not implanted, explanted date: device was not explanted, device manufacture date - unknown due to unknown lot number.510k - k130520.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record and product release decision control sheet.With no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).
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