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
End user reports she was recently diagnosed with a uti.She reports having blood in her urine.She was diagnosed with this uti when she was also hospitalized recently for blood clots and also receiving a heparin drip.She was given iv antibiotics but still having dissipating blood in her urine up to today.Blood in her urine was noted when she was in the hospital as well when uti was diagnosed.A foley was then placed when she was hospitalized and now that foley is out and she is home to restart cic.She has history of utis but also along with foleys in and out of the hospital and does not know the cause of her utis.No additional information was provided.
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be a serious injury.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
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Investigation: this complaint has been evaluated.Investigation conducted retained samples samples from the same lot were inspected: packaging intact, vacuum good, gel coverage normal.No whitening, drying, or hardening observed.Gel appeared transparent and normal.Production review all manufacturing factors were reviewed: man: inspectors and operators fully trained.Machine: packaging machine ran normally; no risk of under geling or gel drying.Material: gel batch viscosity within specifications; no defects.Method: all incoming and in process inspections normal.Environment: no abnormal temperatures during gel storage or production.Measurement: scales calibrated and within validity.High temperature stress test catheters stored at 60 degrees c for 12 days (much higher than reported 41.7 degrees c).Comparisons: unopened pouches: slight gel weight loss but no drying, whitening, or hardening.Opened pouches: more gel evaporation, but still no abnormal gel behavior.Conclusion: high temperature exposure did not reproduce the defect.Key findings root cause ¿ not product related.The investigation concluded: primary cause of infection patient did not clean genital area before catheterization.This strongly increases risk of ascending uti.Matches her history of recurrent utis.Persistent hematuria patient was on heparin anticoagulation, impairing clotting.Infection with mucosal injury led to prolonged bleeding.Product quality no defective materials, no manufacturing deviations.Stress testing disproved heat induced gel drying.Without physical returned samples, no evidence supports product failure.Therefore: the catheter is unlikely to have caused the uti.Corrective & preventive actions no capa actions required because: no product defects confirmed.Root cause attributed to improper user procedure, not product quality.This investigation will be closed.This issue will be monitored through the post market product monitoring review process.Fda registration number 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: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 24027312
• Report Number: 1049092-2026-00006
• Device Sequence Number: 8952435
• Product Code: KOD
• UDI-Device Identifier: 00815947020444
• UDI-Public: 00815947020444
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/08/2026

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
• Device Lot Number: 24B15903
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2024
• 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 Age: 66 YR
• Patient Sex: Female