Date of event: the exact date is unknown; however, it was reported that the event occurred in (b)(6) 2019.The complainant was unable to report the device suspected upn lot number; therefore, the manufacture date and expiration date are unknown.Imdrf patient codes e2330 and e1310 capture the reportable event of pain and urinary tract infection.Imdrf impact codes f08 and f2303 capture the reportable event of hospitalization or prolonged hospitalization and medication 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 an imager ii, nephromax balloon, percutaneous access needle and 8/10 dilator sheath set were used during a percutaneous nephrolithotomy procedure performed in (b)(6) 2019.The patient experienced pain/urinary tract infection (uti).It was reported that the patient had antibiotics and readmission with analgesics.
|