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
Consumer is a 70 yr old female with ms.She reports she has been cathing 2 x a day for retention for 2 yrs now.She states she has always used the ultra14 and it has worked well for her when she is able to get it in her urethra.She is not blaming the catheter for her utis.She has difficulty at times for her entire 2 yrs finding her urethra.This occurs off and on.She has a small mirror but often will try to insert the catheter 2 - 3 times before finding the correct urethral opening.Once in, it will drain well and she has no complaints with the product itself, it is finding the correct spot to place it in.She also is good about always cleansing her genital area with a fragrance free cottonelle brand wipe for cleansing prior to insertion.She reports most recently she had a diagnosed uti about 4 weeks ago.She was previously on low dose nitrofurantoin prescribed by her urologist for prophylaxis uti prevention she estimates for about 6 months prior to the start of this this past uti.She said it must have stopped working for her as she became symptomatic of a uti with urgency, frequency, malodorous urine and dark brown colored urine output.Her urologist had her do a urine specimen which resulted positive for a uti and she was given a treatment course of keflex 500mg tabs she remembers for a few days and then once that was completed her low dose prophylactic antibiotic was changed to continue low dose kelfex 250mg once a day which she said has been taking and working well for her and she is feeling better.Prior to her starting cic 2 yrs ago she has not had utis.Prior to this most recent uti about 4 weeks ago, she did have a few diagnosed utis "a long time ago" - she could not quantify how many but that is why her md had her start on that low dose nitrofurantoin in the past.She also states she does not like to drink a lot of fluids.No photo available.This emdr is to address the uti's with unknown lot and market unit.
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.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: 23388175
• Report Number: 1049092-2025-00235
• Device Sequence Number: 13257820
• Product Code: KOD
• UDI-Device Identifier: 00815947020444
• UDI-Public: 00815947020444
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 10/16/2025

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: ULTRA14
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 10/27/2025
• 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: 70 YR
• Patient Sex: Female