MALE EXTERNAL CATHETER

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

IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED 3 BOXES OF MALE EXTERNAL CATHETERS THAT WERE TOO STICKY AND WERE STUCK TOGETHER AT THE BOTTOM OF THE CONDOM. BECAUSE OF THAT, THE URINE WAS NOT ABLE TO BE LET OUT AND WAS CAUSING MULTIPLE URINARY TRACT INFECTIONS. SENT 2 BOXES OF REPLACEMENTS WITH NONE FOR RETURN. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PRESCRIBED FOR URINARY TRACT INFECTION.