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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Nausea (1970); Pain (1994); Urinary Tract Infection (2120)
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Event Date 12/16/2018 |
Event Type
Injury
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Manufacturer Narrative
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Patient's race is hispanic.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Patient code (b)(6) captures the reportable event of nausea.Patient code (b)(6) captures the reportable event of pain.Patient code (b)(6) captures the reportable event of urinary tract infection.(b)(4).
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Event Description
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It was reported to boston scientific corporation, through a post market clinical follow up (pmcf) of retrospective data collection, that a zero tip basket was used during a ureteroscopy procedure performed on (b)(6) 2018.The patient was readmitted for intractable pain, nausea and urinary tract infection.The patient had multiple emergency room visits.
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Search Alerts/Recalls
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