MAUDE Adverse Event Report: COLOPLAST A/S LUJA COUDÉ URINARY INTERMITTENT DRAINAGE CATHETER (NOT CE MARKED); SINGLE-ADMINISTRATION URETHRAL DRAINAGE CATHETER

Catalog Number	20104
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Urinary Tract Infection (2120); Drug Resistant Bacterial Infection (4553)
Type of Reportable Event	Serious Injury
Event or Problem Description
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.

• Brand Name: LUJA COUDÉ URINARY INTERMITTENT DRAINAGE CATHETER (NOT CE MARKED)
• Common Device Name: SINGLE-ADMINISTRATION URETHRAL DRAINAGE CATHETER
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam holtedam; humlebaek 3050 ; DA 3050
• Manufacturer (Section G): NYÍRBÁTOR
• Manufacturer Contact: usgab giovanna hayford-quansah ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 24109085
• Report Number: 3006606901-2026-00002
• Device Sequence Number: 5816520
• Product Code: EZD
• UDI-Device Identifier: 05701780263252
• UDI-Public: 5701780263252
• Combination Product (Y/N): N
• PMA/510(K) Number: K230165
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 20104
• Device Lot Number: 10461719_2010401400
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown