Date of event: the exact date is unknown; however, it was reported that the event occurred in (b)(6) 2016.The complainant was unable to report the device suspected upn and lot number; therefore, the manufacture date and expiration date are unknown.Adverse event problem: imdrf patient code e2330 captures the reportable event of pain; imdrf impact code f08 captures the reportable event of readmission.
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Note: this report pertains to one of the four devices used in the same patient and procedure.It was reported to boston scientific corporation that an image ii, nephromax balloon, percutaneous access needle and 8/10 dilator sheath set were used during a percutaneous nephrolithotomy (pcnl) procedure performed in (b)(6) 2016.The patient experienced pain and was readmitted.In the physician's assessment the event was not related to the imager ii and 8/10 dilator sheath set but was causally related to the procedure.In the physician's assessment the event was probably related to the nephromax balloon and percutaneous access needle but was causally related to the procedure.
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