|
Model Number 788824 |
Device Problems
Biocompatibility (2886); Patient Device Interaction Problem (4001)
|
Patient Problems
Hemorrhage/Bleeding (1888); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 11/22/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of 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 bard.
|
|
Event Description
|
It was reported that the patient experienced stone formation and stent encrustation, edema, ureteral reflux, hemorrhage, infection, pain and discomfort while using the bard ureteral stent.Medical intervention was unknown.
|
|
Manufacturer Narrative
|
The reported event is inconclusive because no sample was returned.Potential root causes for this event could be, "material selection" or "part geometry".The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: potential complications associated with retrograde/antegrade positioning of indwelling ureteral stents include the following: ¿ edema ¿ stone formation ¿ peritonitis ¿ extravasation ¿ ureteral reflux ¿ stent dislodgement, 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." 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.
|
|
Event Description
|
It was reported that the patient experienced stone formation and stent encrustation, edema, ureteral reflux, hemorrhage, infection, pain and discomfort while using the bard ureteral stent.Medical intervention was unknown.
|
|
Search Alerts/Recalls
|
|
|