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 codes e0734 and e0722 captures the reportable events of pneumothorax and hemothorax.Imdrf impact codes f23 and f08 captures the reportable events of unexpected medical intervention and hospitalization and prolonged hospitalization.
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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 nephromax balloon, percutaneous access needle, imager ii and 8/10 dilator sheath set were used during the percutaneous nephrolithotomy procedure performed in (b)(6) 2021.The patient experienced hemopneumothorax.The patient had undergone oxygen and observation.
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