UNKNOWN URETERAL STENTS

Additional Manufacturer Narrative

THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. THE PRODUCT CATALOG NUMBER FOR THIS DEVICE IS UNKNOWN. THEREFORE, BD IS UNABLE TO DETERMINE THE ASSOCIATED LABELING TO REVIEW. A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. 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

CRITICAL CARE PHYSICIAN REPORTED IN AN ONLINE SURVEY STATED THAT THE PATIENT EXPERIENCED ADVERSE EVENTS (HEMATURIA) ASSOCIATED WITH THE DEVICE INLAY OPTIMA¿ URETERAL STENT WITHOUT GUIDEWIRE. THAT DID NOT RESULT IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. 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

CRITICAL CARE PHYSICIAN REPORTED IN AN ONLINE SURVEY STATED THAT THE PATIENT EXPERIENCED ADVERSE EVENTS (HEMATURIA) ASSOCIATED WITH THE DEVICE INLAY OPTIMA¿ URETERAL STENT WITHOUT GUIDEWIRE. THAT DID NOT RESULT IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION.