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Model Number M0061903320 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fever (1858); Pain (1994); Sepsis (2067); Urinary Tract Infection (2120); Dysuria (2684)
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Event Date 12/04/2022 |
Event Type
Injury
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Manufacturer Narrative
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Study: u0652 double-j registry clinical study.Imdrf patient code e0309 captures the reportable event of sepsis.Imdrf patient code e1301 captures the reportable event of dysuria.Imdrf impact code f08 captures the reportable event of hospitalization.Imdrf impact code f2303 captures the reportable event of medication required.Imdrf impact code f22 captures the reportable event of unexpected diagnostic intervention for the urine culture.
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Event Description
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It was reported that a tria soft ureteral stent was implanted during a laser lithotripsy procedure in the left ureter on (b)(6) 2020, as part of the u0652 double-j registry clinical study.The stent was successfully implanted, and the patient was prescribed an alpha blocker and antibiotic at discharge.On (b)(6) 2022, it was reported that the patient developed sepsis due to a new urinary tract infection (uti).It was noted that the patient had presented to the emergency room with symptoms of bilateral flank pain, dysuria, lower extremity myalgias and a 102-degree fever.Urine cultures resulted with escherichia coli (e coli).The patient was given unasyn, zosyn, levaquin and augmentin.The patient was hospitalized from (b)(6) 2022, to (b)(6) 2022.The patient was discharged with augmentin for two additional days to complete a 7-day course.The event was assessed as possibly related to the procedure and possibly related to the device.On december 16, 2022, the event was considered resolved.
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Event Description
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It was reported that a tria soft ureteral stent was implanted during a laser lithotripsy procedure in the left ureter on (b)(6) 2020, as part of the u0652 double-j registry clinical study.The stent was successfully implanted, and the patient was prescribed an alpha blocker and antibiotic at discharge.On (b)(6) 2022, it was reported that the patient developed sepsis due to a new urinary tract infection (uti).It was noted that the patient had presented to the emergency room with symptoms of bilateral flank pain, dysuria, lower extremity myalgias and a 102-degree fever.Urine cultures resulted with escherichia coli (e coli).The patient was given unasyn, zosyn, levaquin and augmentin.The patient was hospitalized from (b)(6) 2022, to (b)(6) 2022.The patient was discharged with augmentin for two additional days to complete a 7-day course.The event was assessed as possibly related to the procedure and possibly related to the device.On (b)(6) 2022, the event was considered resolved.
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Manufacturer Narrative
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Corrected fields: block h6 patient codes e230101 fever and e1310 urinary tract infection have been added.Block g3: study: u0652 double-j registry clinical study.Block h6: imdrf patient code e0309 captures the reportable event of sepsis.Imdrf patient code e1301 captures the reportable event of dysuria.Imdrf impact code f08 captures the reportable event of hospitalization.Imdrf impact code f2303 captures the reportable event of medication required.Imdrf impact code f22 captures the reportable event of unexpected diagnostic intervention for the urine culture.
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Search Alerts/Recalls
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