Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k) - k130280.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A review of the device history record and product release decision control sheet of the involved product code/lot# combination was conducted with no findings.Review of the shipping inspection record of the involved fiber lot confirmed that the gas transfer performance test and pressure drop test results met the manufacturer control criteria and no anomaly was noted.It is likely that post-operative hematuria urine appeared because hemolysis might have occurred due to some factors.However, with no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).
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