SENSICA URINE OUTPUT SYSTEM

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

IT WAS REPORTED THAT THE SENSICA DEVICE WOULD NOT SUCCESSFULLY COMPLETE OS RE-IMAGE, ASSESSMENT OF OS.

Additional Manufacturer Narrative

THIS SUPPLEMENTAL MDR IS BEING SUBMITTED TO CAPTURE THE INVESTIGATION DETAILS. A REVIEW OF THE RISK DOCUMENT WAS PERFORMED FOR THE INVESTIGATION. THE REPORTED EVENT IS ADDRESSED, AND BASED ON THIS REVIEW, THE RISK ACCEPTABLE; THEREFORE, THIS EVENT IS NOT REPORTABLE. THE DEVICE WAS NOT RETURNED. THE REPORTED ISSUE WAS INCONCLUSIVE. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE IDENTIFIED. THE LATEST LABELING REVISION WAS REVIEWED FOR THIS INVESTIGATION. THE INSTRUCTIONS-FOR-USE UNDER WERE REVIEWED AND FOUND TO BE ADEQUATE. THE IFU CURRENTLY INSTRUCTS THE USER ON THE PROPER METHOD TO USE THIS DEVICE TO AVOID UNDUE INJURY TO THE PATIENT AND DAMAGE TO THE PRODUCT. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. CORRECTION: D UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

IT WAS REPORTED THAT THE SENSICA DEVICE WOULD NOT SUCCESSFULLY COMPLETE OS RE-IMAGE, ASSESSMENT OF OS.