The complainant was unable to provide the device lot number; therefore, the lot expiration and device manufacture dates are unknown.Patient code (b)(4) is being used to capture the reportable issue of pain.(b)(4).The device has not been received for analysis.Upon receipt and completion of the device analysis, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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It was reported to boston scientific corporation, through a post market clinical follow up (pmcf) of retrospective data collection, that lithovue flexscope was used during a left ureteroscopy, left ureteroscopy with laser lithotripsy, right ureteroscopy, right ureteroscopy with laser lithotripsy procedure performed on (b)(6) 2018.The patient was readmitted two days after first procedure for left plank pain, nausea, and fever with a body temperature of 100.5 degrees.The patient required medication to treat the complications.
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