The user facility reported in email correspondence they have had a few serious incidents where the patient has been affected by the bander ureteral diversion stent set.There is an internal investigation in process.This issue has occurred on at least 3 separate occasions.Requests have been made for additional patient, device and event details.This customer reported at least three (3) incidents.These incidents have been captured in three separate medwatch reports.Please see related mfr.Report numbers 1820334-2017-03243, 1820334-2017-03244 and 1820334-2017-03245.
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