C.R. BARD, INC. (COVINGTON) -1018233 BARD® INLAY® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
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Model Number 777626 |
Device Problems
Biocompatibility (2886); Patient Device Interaction Problem (4001)
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Patient Problems
Pain (1994); Skin Discoloration (2074); Swelling/ Edema (4577)
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Event Date 11/22/2021 |
Event Type
Injury
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Event Description
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It was reported that a (b)(6) male patient was admitted to the hospital due to difficulty in urinating.After admission, the doctor diagnosed benign prostatic hyperplasia, and at 10:20 on november 22, the patient was divided into an indwelling ureteral stent.At 17:00, the patient reported that the urethral orifice was painful and accompanied by white secretions.The doctor found that the urethral orifice was red and swollen after examination, so the ureteral stent was removed, and symptomatic anti-inflammatory treatment was given.At 8:30 on november 23, the doctor checked during the rounds.The patient's urethral orifice was normal and there was no secretion.
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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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Manufacturer Narrative
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The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this event could be, "material selection".The device was used for treatment purposes, however, since the device was not returned it is unknown if it had met relevant specifications or contributed to the reported event.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.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 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.Submerge stent in sterile water to activate the coating." 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.
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Event Description
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It was reported that the patient was admitted to the hospital due to difficulty in urinating.After admission, the doctor diagnosed benign prostatic hyperplasia, and at 10:20 on (b)(6), the patient was divided into an indwelling ureteral stent.At 17:00, the patient reported that the urethral orifice was painful and accompanied by white secretions.The doctor found that the urethral orifice was red and swollen after examination, so the ureteral stent was removed, and symptomatic anti-inflammatory treatment was given.At 8:30 on (b)(6), the doctor checked during the rounds.The patient's urethral orifice was normal and there was no secretion.
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Search Alerts/Recalls
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