BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER

Additional Manufacturer Narrative

THE INITIAL REPORTER'S PHONE NUMBER: (B)(6). THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THIS REPORT REFERENCES A US EQUIVALENT DEVICE. THE US UDI EQUIVALENT FOR THIS PRODUCT NUMBER IS USED. H11: SECTIONS 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 THIS CONSTITUTES A DRAINAGE DIFFICULTY INCIDENT. PLEASE REPORT THIS BECAUSE DRAINAGE TOOK A LONG TIME AND THE WATER HAS NOT BEEN COMPLETELY DRAINED.