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

Model Number	ULTRA M14C
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Type of Reportable Event	Malfunction
Event or Problem Description
End user states "there are areas on the catheter near and/ or on pointed coude tip that are scratching him with use as they do not feel smooth as he is used to with this product." he states "it is in the beginning part, not sure where." he said "he ran his fingers along it after removal of ones like this and felt the defect but couldn't see it.He always places the catheter in with the coude tip upwards correctly.Could not provide any further details at this time.He said he can feel this defect more so in his urethra right at the beginning on entry or sometimes even a little further in, no more than the first 3 inches in.When this defect is felt, he will not continue to use the catheter to drain his bladder, removes it and just gets a new one that does not have the issue.He has not had any bleeding with this issue.He said the pain goes away quickly without intervention.".
Additional Manufacturer Narrative
E1: complainant street address: (b)(6).Complainant phone: (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.
Additional Manufacturer Narrative
Investigation: ¿ 10 retained samples were examined, revealing gel coating on the tips and eyelets.Once rinsed, the samples appeared smooth, with no abnormalities detected.¿ a previous complaint from january 10, 2025, regarding rough eyelets was considered, leading investigators to focus on the tip production process.¿ the 5m1e method was applied, covering personnel, machinery, materials, methods, environment, and measurements.¿ personnel were adequately trained, equipment functioned correctly, and production methods followed official guidelines.¿ both in-process and final inspections found no abnormalities.Findings: no defects were found in the retained samples, and since no physical products or related photos were received, the cause of the issue could not be determined.Root cause: due to the lack of physical evidence, the investigation was inconclusive, and the root cause could not be identified.Corrective action: as the root cause remains unknown, no corrective or preventive measures were implemented.However, quality monitoring will continue.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.
Additional Manufacturer Narrative
Investigation: · 10 retained samples were examined, revealing gel coating on the tips and eyelets.Once rinsed, the samples appeared smooth, with no abnormalities detected.· a previous complaint from january 10, 2025, regarding rough eyelets was considered, leading investigators to focus on the tip production process.· the 5m1e method was applied, covering personnel, machinery, materials, methods, environment, and measurements.· personnel were adequately trained, equipment functioned correctly, and production methods followed official guidelines.· both in-process and final inspections found no abnormalities.Findings: no defects were found in the retained samples, and since no physical products or related photos were received, the cause of the issue could not be determined.Root cause: due to the lack of physical evidence, the investigation was inconclusive, and the root cause could not be identified.Corrective action: as the root cause remains unknown, no corrective or preventive measures were implemented.However, quality monitoring will continue.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 LTD; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• 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: 21373862
• Report Number: 1049092-2025-00058
• Device Sequence Number: 20969914
• Product Code: EZD
• UDI-Device Identifier: 00815947021113
• UDI-Public: 00815947021113
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K221593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2025

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: ULTRA M14C
• Device Lot Number: 24B08001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 05/08/2025; 05/08/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 05/27/2025; 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2024
• 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