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

Model Number	ULTRA M12C
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Malfunction
Event or Problem Description
End user reports "half of them were completely dry lacking any lubricant at all on them.He said he tried to insert some like this and they would stop halfway through urethra as they were unlubricated.He said it hurt his urethra putting them in but also with removal.He said he took some ibuprofen and the pain in his urethra went away in about a half hour.Denies any bleeding or further interventions.He said he then applied lubricant to the ones like this so he could get them to glide in.".
Additional Manufacturer Narrative
Device 5 of 15.Based on the available information, this event is deemed to be a reportable malfunction.Convatec has come to the business decision cross function with regards to the complaints below that there is no further action required at this stage.Hydrophilic - stick packaging.Ultra - insufficient lubricant.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: 23749451
• Report Number: 1049092-2025-00306
• Device Sequence Number: 5854968
• Product Code: EZD
• UDI-Device Identifier: 00815947021106
• UDI-Public: 00815947021106
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: ULTRA M12C
• Device Lot Number: 25B08101
• 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: 11/18/2025
• Initial Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2025
• 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: Male