MAUDE Adverse Event Report: CONVATEC INC CURE ULTRA CATHETER; CATHETER, UROLOGICAL

Model Number	ULTRA10
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
End user reports she "continued to have recurrent utis many months in a row month diagnosed at urgent cares and her md since we last spoke.She said she had one diagnosed each month in (b)(6)t and feels like she has another one now in november.The urine cultures always grow out the same bacteria the last few months, klebsiella pneumoniae.Her symptoms are always urgency frequency and burning.For her prior utis in (b)(6) she said she always felt better for a few weeks after antibiotic treatment before the new one started.Her symptoms returned again in (b)(6).The end of (b)(6) after a treatment course of antibiotics for a positive uti (stated she was started on cefindir but when that came back as resistant and she was switched to another antibiotic - name cno) she said she did check her urine culture and it showed no growth but she still felt symptomatic.She said she recently went to urgent care to do another urine test due to her symptoms not going away and has yet to hear back on most recent results but suspects another uti.She saw her urologist (b)(6) in person for follow up but they are just monitoring her.She still has a small kidney stone they are monitoring as well." she follows a non-bladder irritating diet and she takes all precautions to prevent utis.".
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be a serious injury.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.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.

• Brand Name: CURE ULTRA CATHETER
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 23521604
• Report Number: 1049092-2025-00272
• Device Sequence Number: 18588320
• Product Code: KOD
• UDI-Device Identifier: 00815947020420
• UDI-Public: 00815947020420
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 11/10/2025

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: ULTRA10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 11/11/2025
• 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 Age: 67 YR
• Patient Sex: Female