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

Model Number	ULTRA M14C
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 states he "has been cathing since (b)(6) 2025 with the ultram14c catheter.He just previously had pae procedure for his bph on (b)(6) 2025.He had a foley post op, it was removed after a few days and he ended up failing that voiding trial.He said a new foley was placed however he ended up getting a bad uti end of october with shaking chills and fever from it.He said that was successfully treated his symptoms of that uti and removed and he started cic.He said since he started cic he has had 2 additional utis with his intermittent catheters following the first one post op with the foley.His symptoms post foley infection cleared with antibiotic treatment.Then end of (b)(6) 2025 he noticed he had cloudy urine that was foul smelling and a urine culture was checked which was positive for enterococcus and he was treated with macrobid.He said the antibiotic helped a lot to clear his urine cloudiness but not sure if it ever fully cleared up post treatment.He said he went into see his urologist last thursday because he had an episode wednesday night where he placed the catheter in him and urine sprayed out all around the catheter and it was hard to insert and uncomfortable.He was able to get in another catheter on his second try and he was able to fully drain.When he saw the urologist his post void residuals were low at about 125ml he said.His urologist advised him ok to drop down to cic 2-3 times a day (from 3 -4 x a day) as long as he stays below 500 mls with his cath'd voids post residual.He said a urine was checked as well in the office.He said his only symptom was cloudy urine and a little burning but nothing too alarming out of the ordinary.He said at times he feels like his meatus is closed shut and he has to pry it open a bit with the catheter.He said he just received an electronic message from his md that he should start levaquin antibiotic for a week as his urine culture isn't finalized but looking like he has another uti.He only suspects that possibly that catheter upon removal from packaging can touch the lettuced torn edges (partially outside of packaging) of where it was torn on top, thinking maybe this could have contributed to his past utis, he is not sure.Consumer was advised not use any product that he sees was contaminated prior to insertion.His md said his prostate is still enlarged possibly attributing to his retention and may need another surgery.He also suffers from constipation." this emdr covers the unknown number of catheters associated with the 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 MALE CATHETER
• Common Device Name: CATHETER, STRAIGHT
• 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: 24208631
• Report Number: 1049092-2026-00014
• Device Sequence Number: 21248166
• Product Code: EZD
• UDI-Device Identifier: 00815947021113
• UDI-Public: 00815947021113
• 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): 01/26/2026

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: ULTRA M14C
• 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: 01/26/2026
• Initial Report FDA Received Date: 01/29/2026
• 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: Male