MAUDE Adverse Event Report: CONVATEC CURE CATHETER CLOSED SYSTEM; TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)

Model Number	CS12
Medical Device Problem Codes	Difficult to Remove (1528); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device 6 of 20 based on the available information, this event is deemed to be a reportable malfunction.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
It was reported by the mother of a 25 yo female that the bag portion of the catheter is stuck in individual packaging seals.The consumer has cath'd with this product for 8 yrs now and caths through her urethra.She gets 200 catheters per month, 2 cases.She reports that she has found 20 catheters that have this same defect.Both cases have the same lot and these 20 have come from both cases so far.She said the bag of the catheter itself is stuck in the side heat seal of the catheters individual packaging.She said it tends to be stuck on the bottom of the bag to the bottom seal of the packaging.If she pulls the bag out, it will tear the catheter's bag.They have not used ones like this with the reported defect and the majority have been discarded but she said she has kept 2 with the defect and can send photos of the concern.There was no harm.No additional information was provided.

• 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: courtney smith ; 7815 national service road; suite 600; greensboro, NC 27409 ; 6032470255
• MDR Report Key: 24681793
• Report Number: 1049092-2026-00061
• Device Sequence Number: 9726812
• Product Code: FCM
• UDI-Device Identifier: 00815947020666
• UDI-Public: 00815947020666
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: CS12
• Device Lot Number: 25B14402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 05/07/2026; 05/07/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 05/22/2026; 05/23/2026
• 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 Age: 25 YR
• Patient Sex: Female