Luja Coude 20104Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05701780263252), received between Jan 19, 2026 and Jan 27, 2026 — classified as 2 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT ACQUIRED AN INFECTION WHILE USING SPEEDICATH COUDE (20104 LOT 10294663 FROM BYRAM). THE PATIENT WAS HOSPITALIZED FOR UTI AND SEPSIS. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: Sepsis; Urinary Tract Infection

  MAUDE report 24188739 ↗
• InjuryJan 19, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THIS COMPLAINT CONCERNS A PATIENT WHO HAS USED THE LUJA COUDE URINARY INTERMITTENT DRAINAGE CATHETER FOR ABOUT A MONTH. THE PATIENT¿S WIFE REPORTED THAT THE END USER HAS EXPERIENCED BLEEDING ONCE IN A WHILE AND DEVELOPED A UTI THAT RESULTED IN AN OVERNIGHT HOSPITAL STAY WITH IV ANTIBIOTICS. THE END USER WAS SENT HOME WITH ANTIBIOTICS AND IS NO LONGER SYMPTOMATIC. IT IS REPORTED THAT THE BLEEDING WAS VISIBLE IN THE CATHETER AND/OR THE URINE. THE PATIENT DID NOT FORCE THE CATHETER INTO THE URETHRA AND BLADDER. THE BLEEDING STOPPED IMMEDIATELY AFTER THE CATHETER WAS REMOVED. THERE WERE NO OTHER HEALTH EFFECTS BESIDES THE BLEEDING. THEY RECEIVED TRAINING ON HOW TO USE THE CATHETER AND DID SO ACCORDING TO THE IFU. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: Drug Resistant Bacterial Infection; Hemorrhage/Blood Loss/Bleeding; Urinary Tract Infection

  MAUDE report 24109085 ↗