Block h6: imdrf patient code e1302 captures the reportable event of hematuria.Imdrf patient code e1302 captures the reportable event of pain.Imdrf impact code f23 captures the reportable event.Block h10: the returned polaris loop ureteral stent was analyzed, and a visual evaluation noted that stent calcification was found all over the shaft and in the renal coil.Additionally, the patient and impact codes reported is a condition that could not be tested, analyzed or replicated on the product analysis laboratory; therefore, those events are not confirmed.The reported pain and hematuria, and the founded calcification on the complaint are a known adverse event associated with the use of the device and it is noted within the dfu, polaris loop, ver, ae.Taking all available information into consideration, all compiled information on this investigation determines that the most probable cause is known inherent risk of device since the hematuria and pain reported by the physician are known and documented in the labeling so the calcified encountered.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
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