Luja Coude 20106Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05701780263269), received between Apr 4, 2024 and Apr 4, 2024 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINT DESCRIBES AN END-USER WHO PERFORMED INTERMITTENT CATHETERIZATION WITH THREE LUJA CATHETERS AND EXPERIENCED BLEEDING. THE END-USER WAS ADMITTED IN EMERGENCY ROOM FOR 4 DAYS WHERE THE BLEEDING HAD STOPPED. THE END-USER DID NOT EXPERIENCE ANY PAIN WHILE CATHETERIZING AND DID NOT SEE ANY NOTICEABLE PRODUCT DEFECTS OR SHARP EDGES. THE END-USER ALSO MENTIONS HIS PROSTATE IS ESTIMATED TO BE SIX TIMES THE NORMAL SIZE AND THE END-USER REVEALED HE DID FORCE THE CATHETER INTO THE URETHRA AND BLADDER AND HAS NOT RECEIVED TRAINING IN SELF- CATHETERIZATION. FURTHERMORE, THE END-USER HAD A FOLEY CATHETER INSERTED AND ANTIBIOTICS FOR URINARY TRACT INFECTION PREVENTION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19043026 ↗