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

Model Number	ULTRA M14C
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 reports qty 1 affected from 1 mu box, part at the tip/ beginning of catheter that is not smooth, scratching him with use.He states he found another catheter in a new mu from his 90 day shipment he just got with the continued issue.He said it seems to be rough scratchy part on the right side of the catheter near the tip area of the catheter.He did not use to place the length of his urethra to drain his bladder after feeling this issue at the start of urethra.He said it felt scratchy and he removed it, pain dissipated quickly without intervention.He did not keep it and it has been discarded.End user reports pain of a scratchy feeling with attempted use.Did not continue to place and removed, pain dissipated quickly without intervention.No photo available.
Additional Manufacturer Narrative
Investigation findings: sample testing: 10 retained samples were inspected.All appeared smooth to the touch and showed no abnormalities after gel removal and magnified inspection.Personnel: all involved staff were properly trained and certified; no issues found.Equipment: automatic catheter machine (yjg007) with visual inspection system operated normally during production.No faults or parameter deviations were reported.Root cause & corrective action: root cause: cannot be determined due to lack of physical evidence or photos.Production and inspection processes were normal.No corrective or preventive actions are being taken at this time, but the company will continue monitoring product quality.Supplier report has been attached to child investigation record.This investigation will be closed.This issue will be monitored through the post market product monitoring review process, sop-000741.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 ; 3365424679
• MDR Report Key: 21773465
• Report Number: 1049092-2025-00136
• Device Sequence Number: 13186878
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

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: 24B13602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2024
• 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