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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It was reported critical care nurses reported in an online survey that the patient experienced an adverse event directly attributable to the device "786600 - inlay optimatm multi-length ureteral stent with nicore¿ guidewire, 6 fr., 22cm ¿ 32cm " and the patient experienced "pain or discomfort" and "urinary symptoms".This did not resulted in the patient injury requiring medical or surgical intervention.
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