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

Model Number	ULTRA 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
Consumer reports he "has been self cathing for several years for bph.He said some of the catheters in the box had rough eyelets in which caused discomfort and light bleeding with use.He said he could feel the sharpness around the eyelets the entire length of his urethra saying it "felt very rough internally".He did not feel the eyelets with his hand upon removal.He said he had light bleeding and small clots for about 3 days off an on with use of these sharp eyelet catheters.Bleeding dissipated on its own.He said he did not relay this to his md but said he knows his md just tells him to flush it out by pushing fluids which is what he did and it stopped on i's own.".
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
13 retained samples were checked, and all the samples appeared normal, with intact individual packaging.The tube was observed to be covered with gel, with good vacuum packaging and the blister cavity in the contracted stated, evenly wrapping the catheter.The production and inspection processes are operating normally, and sample retention tests show no abnormalities.The root cause of the reduced gel quantity has not been determined at this time.Sharp eyelets: details information regarding the catheter that allegedly caused user bleeding has not been received.Therefore, it cannot be concluded that burrs on the catheter¿s side holes are the root cause of the user¿s bleeding.The root cause of the insufficient gel amount cannot be determined at this time.So, no correction action.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, UROLOGICAL
• Manufacturer (Section D): CONVATEC LTD; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer (Section G): CONVATEC LTD; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 21217704
• Report Number: 1049092-2025-00044
• Device Sequence Number: 3378130
• Product Code: KOD
• UDI-Device Identifier: 00815947021069
• UDI-Public: 00815947021069
• 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): 01/21/2025

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 M14
• Device Lot Number: 24B04501
• 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: 01/21/2025
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2024
• 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