SPEEDICATH SOFT

Additional Manufacturer Narrative

THIS COMPLAINT DESCRIBES TWO WELL-KNOWN SIDE-EFFECTS OF INTERMITTENT CATHETERIZATION, BLEEDING AND UTI. BOTH ARE INCLUDED IN THE PRODUCT RISK ASSESSMENT FOR THE INVOLVED PRODUCT. THE RECEIVED PRODUCT SAMPLES WERE ANALYZED AND MET THE PRODUCT SPECIFICATIONS. NO DEVIATION WAS FOUND THAT COULD CONTRIBUTE TO THE REPORTED INCIDENT. THE REVIEWED PRODUCTION DOCUMENTS DID NOT REVEAL ANY NONCONFORMITIES RELATED TO THE REPORTED LOT NUMBERS THAT COULD BE RELATED TO THE REPORTED INCIDENT. BASED ON THE OBSERVATION OF THE RETURNED SAMPLES THIS COMPLAINT CANNOT BE VERIFIED. WE CONTINUOUSLY MONITOR THE COMPLAINT TRENDS AND REPORT IT TO THE MANAGEMENT.

Additional Manufacturer Narrative

SPEEDICATH SOFT CATHETERS WITH DIFFERENT LOT NUMBERS WERE UTILIZED BY THE END USER (7650187, 7738956). THESE LOT NUMBERS WILL BE FILED UNDER SEPARATE MFR#'S. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. ONCE OUR EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

THIS CASE INVOLVES A (B)(6)-YEAR-OLD MALE, WHO USES INTERMITTENT CATHETERS. THE END-USER IS NEW TO SC SOFT CATHETER AND THE FIRST TIME HE TRIED IT, HE HAD TO PUSHED HARDER THAN USUAL TO INSERT THE CATHETER. HEREAFTER, HE HAD BLOOD AND LARGE SCABS IN HIS URINE FOR ABOUT ONE WEEK. HE DID NOT SEEK MEDICAL HE HAD EXPERIENCED THIS BEFORE WITH RED RUBBER CATHETERS. HIS DOCTOR HAD, AT THAT TIME, INFORMED HIM THAT IT WAS BECAUSE OF AN ENLARGED PROSTATE WHICH THE END-USER STATES SOMETIMES ¿GETS IN THE WAY¿. DURING THE WEEK WITH BLEEDING, HE CONTINUED TO CATHETERIZE, BUT WAS MORE CAREFUL. INSPECTION OF THE CATHETERS DID NOT FIND ANY ISSUES WITH THE CATHETERS. TWO DAYS AFTER THIS IT WAS REPORTED THE END-USER WAS IN THE HOSPITAL DUE TO A URINARY TRACT INFECTION (UTI). THE END-USER STATES THAT THE HOSPITAL DID NOT THINK THE REASON FOR THE UTI WAS RELATED TO THE CATHETERS, BUT DUE TO HIS RECENT TREATMENT WITH ANTIBIOTICS AFTER A MAJOR DENTAL PROCEDURE, WHICH HAVE AFFECTED HIS IMMUNE SYSTEM. DURING HIS HOSPITAL STAY HE WAS PROVIDED WITH AN INDWELLING CATHETER. EXAMINATION SHOWED THAT THERE WAS NO DAMAGE TO THE BLADDER WALL, AND THE DOCTOR THINKS THE BLOOD WAS FROM THE ENLARGED PROSTATE. THE END-USER IS NOW OUT OF THE HOSPITAL, THE INDWELLING CATHETER HAS BEEN REMOVED AND HE IS CONTINUING TO USE INTERMITTENT CATHETERS. HE EXPERIENCED SOME MINOR BLEEDING WHEN TRYING THE CATHETERIZE WITH A SC FLEX COUDE PRO CATHETER; BUT BELIEVES THIS WAS DUE TO THE PROSTATE AGAIN. HE HAS MOSTLY RECOVERED AND IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.