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
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.
Event or Problem Description
End user states "for about a year now she has remained uti free, continuing to use the ultra10, but last month on (b)(6) did go in to see her urologist with one of the worst utis she has ever had she said.She had pus draining from her urethra and bad urethral pain.She did a urine culture which was positive for uti and prescribed 2 different antibiotics.She felt like it never got better and still not 100% better, even now, but much better than how she was.She is on her last antibiotic pill today and actually did another urine test last friday (b)(6) 2025 (while she was still on antibiotics) due to her continued symptoms is still waiting for those culture results as they arrived to the lab on monday she was told.She is following up with her md.She still has a small kidney stone they are monitoring." her technique was discussed and she states she is very cautious to follow all proper steps for cleanliness.She also said after bowel movements she will also wash herself very well even in the shower with soap and water.".

• 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: 22838179
• Report Number: 1049092-2025-00220
• Device Sequence Number: 9404385
• 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): 08/14/2025

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: 08/14/2025
• Initial Report FDA Received Date: 08/19/2025
• 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