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
End user states "he caths due to retention his as his bladder cannot empty on it's own noting possibly the muscle sphincter/ muscular issue could be the cause.He does not have an enlarged prostate.He started cathing about 3- 4 yrs ago for retention and has used this catheter since then.He said when he first started cathing he started having few utis but not very many.He said this year he has more utis than ever and his urologist does not know why he said.He said he had one in january, then february (both diagnosed by urine sample and treated with antibiotics) and most recently had one diagnosed oct 22.He said about 20 days or so before that he had been diagnosed with a uti as well.He said he was symptom free for 2-3 days after being on 10 day course of bactrim ( he knows he has a uti when symptom of malodorous smelling urine, urine has a fishy very strong smell he said) before the smell came back.As of oct 22nd, his md has placed him on another course of antibiotics (name cno) he is taking now, feeling better.He said with this catheter, more recently this started could not pinpoint when, often has a feeling of "burning" at the tip of his penis and possibly developing a sensitivity to the lubricant.He said this burning can last 20 min or so after cic before going away on its own.He has no allergies he is aware of.He said he is very careful with hygiene as he knows this is important for uti prevention.He washes his hands with antibacterial soap, cleanses his tip of penis with an alcohol wipe and ensures to not contaminate catheter." end user was advised alcohol can be drying in that area and to discuss also other wipe options with his md.
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: 23414463
• Report Number: 1049092-2025-00251
• Device Sequence Number: 21407468
• Product Code: EZD
• UDI-Device Identifier: 00815947021113
• UDI-Public: 00815947021113
• Combination Product (Y/N): N
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/24/2025

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: 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: 10/24/2025
• Initial Report FDA Received Date: 10/29/2025
• 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: 73 YR
• Patient Sex: Male