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Model Number 788600 |
Device Problems
Biocompatibility (2886); Patient Device Interaction Problem (4001)
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Patient Problems
Unspecified Infection (1930); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/03/2021 |
Event Type
Injury
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
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Event Description
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It was reported that the user experienced edema, ureteral reflux, pain/discomfort, hydronephrosis, infection, urinary symptoms.Stone formation, stent dislodgement, migration, occlusion, stent encrustation while using the ureteral stent.It was unknown what medical intervention was provided for edema, infection and urinary symptoms.
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Manufacturer Narrative
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The reported event was inconclusive.No sample was returned for evaluation.The device was used for treatment purposes, however, it is unknown if the device had met relevant specifications or contributed to the reported event.A potential root cause for this event could be, "material selection".The lot number was 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" "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." "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." correction: f.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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Event Description
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It was reported that the user experienced edema, ureteral reflux ,pain/discomfort, hydronephrosis, infection, urinary symptoms, stone formation, stent dislodgement, migration, occlusion, stent encrustation while using the ureteral stent.Medical intervention was unknown.
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Search Alerts/Recalls
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