MAUDE Adverse Event Report: CONVATEC CURE PRODUCTS; CATHETER, STRAIGHT

Model Number	M12
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1: (b)(6).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
End user reported he has been using cure catheters for a few years now.He says that with x1 catheter in his box, he felt an intense pain with catheter insertion as well as with catheter removal.It was after he catheterized that he noted a piece of what looks like adhesive, stuck on the catheter tip going up 3-4 inches.He did not see any bleeding post catheterization.Currently, he has no pain.No additional information was provided.
Additional Manufacturer Narrative
Investigation: investigators ruled out foreign matter originating from the manufacturing process.They examined personnel training, production procedures, material inspections, and environmental factors.Findings: the foreign object likely came from a damaged self-adhesive card sleeve used in the catheter inspection area.Over time, pieces of the aging sleeve detached and may have accidentally adhered to a catheter.Root cause: the workshop failed to replace the damaged self-adhesive card sleeve on time, allowing aging fragments to fall off and mix into the production environment, eventually adhering to a catheter.Corrective action: the workshop will inspect and replace worn adhesive sleeves to prevent similar issues.The corrective action plan was finalized on april 30, 2025.This investigation will be closed.This issue will be monitored through the post market product monitoring review process, (b)(4).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
To date no additional patient or event details have been received.

• Brand Name: CURE PRODUCTS
• Common Device Name: CATHETER, STRAIGHT
• 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: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3367062840
• MDR Report Key: 20558658
• Report Number: 1049092-2024-00126
• Device Sequence Number: 13006841
• Product Code: EZD
• UDI-Device Identifier: 00815947020024
• UDI-Public: 00815947020024
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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: M12
• Device Lot Number: 22B41601
• 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: 10/23/2024
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 05/26/2025
• Date Device Manufactured: 03/01/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male