LUJA FEMALE URINARY INTERMITTENT DRAINAGE CATHETER

Description of Event or Problem

ACCORDING TO THE AVAILABLE INFORMATION, THIS COMPLAINT CONCERNS A FEMALE PATIENT WHO HAS RECENTLY STARTED USING THE LUJA FEMALE CH10. THE PATIENT HAD TO BE BROUGHT TO THE HOSPITAL DUE TO THE LUJA BEING STUCK INSIDE HER URETHRA AND NEEDED A FLEXIBLE CYSTOSCOPY TO REMOVE THE CATHETER. SHE HAS SINCE BEEN DISCHARGED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

Additional Manufacturer Narrative

THIS COMPLAINT DESCRIBES AN INCIDENT WHERE THE LUJA FEMALE CATHETER BROKE INSIDE A PATIENT, WHO NEEDED MEDICAL INTERVENTION TO GET THE PART REMOVED. THE TYPE OF INCIDENT IS COVERED IN THE PRODUCT RISK ASSESSMENT AND 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.