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

Model Number	M14
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Malfunction
Event or Problem Description
End user reports he has been using this catheter for years now 2 x day for retention.He said in his recent 3 month order he found a few, estimates about 5-10% from 6 mu boxes that were sticking to the packaging, specifically the plastic side near the tip.He said he would have to pull hard to get them out.He still used them.He said some would feel rough, sharp at the spot where they stuck to packaging.He would always apply lubricant like he normally does.He had some light bleeding, only at times with use of these with the issue.No additional medications/interventions for this.He also mentioned he also recently had a laser procedure for kidney stones and had a foley for a short time following that procedure and so thought maybe some of the bleeding/ irritation could have been from that as well.He did say that he was using catheters with this defect just before and after foley removal when he restarted cic.No photo available (they were used and discarded).
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.
Additional Manufacturer Narrative
Investigation: this complaint has been evaluated.Conclusion no abnormalities found in production or inspection.Root cause undetermined due to lack of physical evidence.No corrective or preventive actions initiated at this time.Manufacturer will continue monitoring and follow up if additional evidence is provided.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 CATHETER
• 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: 22862084
• Report Number: 1049092-2025-00219
• Device Sequence Number: 7632263
• Product Code: EZD
• UDI-Device Identifier: 00815947020031
• UDI-Public: 00815947020031
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2025

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: M14
• Device Lot Number: 24B29304
• 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: 08/11/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2024
• 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