MAUDE Adverse Event Report: ConvaTec CURE CATHETER CLOSED SYSTEM; Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

Model Number	CS14
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be a serious injury.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 3005471919.
Event or Problem Description
End user states "he said some would go in the first inch and will fold back, some others won't go in his urethra at all as they are too flexible.He has no stricture/scar tissue he is aware of.Others he could not pass his prostate and some fold at this point and others just won't pass as they lack the rigidity that he is used to with this product.He said at times it will be 5 in a row that won't go in and then he will try another one and have no problems at all.He said he will go weeks without this being an issue and then he will get another 3 in a row that will give him the same trouble.He said due to the trouble of not being able to pass a few he did experience bleeding.He does not bleed often but states he is prone to utis with bleeding events.The bleeding was slight and only was noted on ends of catheters and a little on a pad before stopping on its own.After he had malodorous urine and cloudy urine and went to see his infectious disease md.They checked his urine and he was found to have a uti and prescribed a week treatment dose of bactrim which cleared up his symptoms.He said they checked his psa and his prostate and nothing appeared too swollen.He has regular follow up with his urologist next month.He manages his bowels to avoid constipation by eating fiber rich cereal, apple and yogurt daily." end user was advised regarding pelvic floor relaxation techniques, deep breathing and he was appreciative as he was not aware of that.He said he does not feel the issue is with him but the product because it doesn't make sense how he does nothing differently, but some go in easy and others give him this trouble being too flexible.He even added more lubricant to some to see if that would help but it didn't make much of a difference." it was discussed with end user his usage of the catheter, and he was not aware of placement of introducer tip first into his urethra and then passing the catheter through it.He was never taught that, he was appreciative of the information.

• Brand Name: CURE CATHETER CLOSED SYSTEM
• Common Device Name: Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
• Manufacturer (Section D): ConvaTec; 7815 national service road; suite 600; greensboro NC 27409
• Manufacturer (Section G): ConvaTec; 7815 national service road; suite 600; greensboro NC 27409
• Manufacturer Contact: armando cuello ; 7815 national service road; suite 600; greensboro, NC 27409 ; +1(603)247-0255
• MDR Report Key: 50789141
• Report Number: 1049092-2026-0000264
• Device Sequence Number: 18784311
• Product Code: FCM
• UDI-Device Identifier: 00815947020673
• UDI-Public: 00815947020673
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080881
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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 Model Number: CS14
• Device Lot Number: 25B10601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male