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

Catalog Number	20106
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : device not returned to manufacturer.
Event or Problem Description
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.
Additional Manufacturer Narrative
Device was not returned.

• 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 humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usgab giovanna abugre ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 19043026
• Report Number: 3006606901-2024-00008
• Device Sequence Number: 20671181
• Product Code: EZD
• UDI-Device Identifier: 05701780263269
• UDI-Public: 05701780263269
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2024

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 Expiration Date: 07/07/2025
• Device Catalogue Number: 20106
• Device Lot Number: 9258979_2010601400
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2023
• 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
• Patient Age: 76 YR
• Patient Sex: Male