Date of event: the exact date is unknown; however, it was reported that the event occurred in (b)(6) 2021.The complainant was unable to report the device suspected upn and lot number; therefore, the manufacture date and expiration date are unknown.Imdrf patient code e1310 captures the reportable event of pyelonephritis.Imdrf impact codes f08 and f2303 capture the reportable event of readmission and medication (antibiotics) required.
|
Note: this report pertains to one of four devices used in the same patient and procedure.It was reported to boston scientific corporation that a nephromax balloon, introducer needles, imager ii, and 8/10 dilator sheath set were used during the percutaneous nephrolithotomy procedure performed in (b)(6) 2021.The patient experienced pyelonephritis.The patient had to be readmitted and was given antibiotics.
|