MAUDE Adverse Event Report: ConvaTec CURE ULTRA CATHETER; Catheter, Urological

Model Number	ULTRA14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported "patient is keeping uti's for a long while now and has to stay on antibiotics all the time".No lot number provided.
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be a serious injury.A complaint investigation has been initiated.Unfortunately, as no specific lot number was identified, it limits the ability to trace or analyze a particular item.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Reporting site: 1049092.Manufacturing site: 3005471919.

• Brand Name: CURE ULTRA CATHETER
• Common Device Name: Catheter, Urological
• 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: pam meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; +1(603)247-0255
• MDR Report Key: 50693528
• Report Number: 1049092-2026-0000263
• Device Sequence Number: 9685058
• Product Code: KOD
• UDI-Device Identifier: 00815947020444
• UDI-Public: 00815947020444
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: ULTRA14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female