It was reported that a physician stated in an online survey that they experienced urinary symptoms and hematuria prior to the device placement, and urinary symptoms, hematuria complications were directly attributable to the device and tablets were needed for urinary symptoms in relation to inlay optima ureteral stent without guidewire, 6 fr.X 24cm.
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
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The reported event is inconclusive as no sample was returned.Although an exact root cause could not be determined a potential root cause could be material selection.The dhr review is not required as no lot number was provided.The instructions for use were found adequate and states the following: "potential complications associated with retrograde/antegrade positioning of indwelling ureteral stents include the following: edema, stone formation , peritonitis, extravasation , ureteral reflux , stent dislogdgement, fragmentation, migration, occlusion, fistula formation, loss of renal function , hemorrhage , pain/discomfort , stent encrustation , hydronephrosis, perforation of kidney, renal pelvis, ureter and/or bladder, ureteral erosion, infection ,urinary symptoms." "determine the proper stent length for the patient.This is generally calculated from the baseline pyelogram.Accurate measurements will optimize drainage efficiency and patient comfort." "the insertion of a ureteral stent should only be done by those individuals who have comprehensive training in the techniques and risks of the procedure." h11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
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It was reported that a physician stated in an online survey that they experienced urinary symptoms and hematuria prior to the device placement, and urinary symptoms, hematuria complications were directly attributable to the device and tablets were needed for urinary symptoms in relation to inlay optima ureteral stent without guidewire, 6 fr.X 24cm.
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