MAUDE Adverse Event Report: CONVATEC INC CURE PRODUCTS; CATHETER, UROLOGICAL

Model Number	ULTRA M16
Medical Device Problem Code	Device Handling Problem (3265)
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.The identification code, uca-pmc13.02, is not associated with a design or manufacturing-related complaint issue.Therefore, a detailed investigation or batch record review is not required.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 he has been "catching for the past 5 years from retention, unknown reason why he had to begin cic.He caths every 4-5 hrs.He said he has used this same catheter brand/ type for 5yrs and has no difficulty using it and likes this catheter.He did not have utis previously the first few years of cic but says only more recently started getting utis which he is hospitalized for each time.He said "since thanksgiving has been hospitalized 3 times" and prior to that had 2 prior utis where he was hospitalized.He said he is currently in the hospital for 4 days on iv antibiotics and has had a foley placed for the past 4-5 days and is planning to have it removed so he can start cic again.The uti just prior to this current uti was about 5 weeks ago and said his symptoms had fully resolved after that antibiotic treatment for about 4 weeks.Each of his utis his only symptom is whole body fatigue - it really "knocks him out" and he can't even stand/ walk.He said he is always carried or brought by wheelchair to the hospital each of his 5 diagnosed utis and he is found to have a uti in his urine and treated with iv antibiotics and sent home on oral antibiotics and his symptoms resolve.He called as he believes his infections are occurring due to his catheter use in general." his routine was discussed and he states, "he does not typically wash his hands prior to cic; he just uses a baby wipe on his hands and also his penis (the same one) and just wipes his penis "round and around" (he is circumcised).He also does not ever utilize the blue no touch gripper, said he didn't know what it was for all these years, as he said he uses "his fingers and nails to grip the catheter" itself with insertion." proper hygiene techniques were discussed that he can take to prevent utis as much as possible - discussed proper hand washing, cleansing techniques of penis as well as importance of not contaminating catheter with use.".

• Brand Name: CURE PRODUCTS
• 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: 22342697
• Report Number: 1049092-2025-00178
• Device Sequence Number: 14674857
• Product Code: KOD
• UDI-Device Identifier: 00815947021076
• UDI-Public: 00815947021076
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 06/09/2025

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 M16
• Device Lot Number: 24B16104
• 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: 06/09/2025
• Initial Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2024
• 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: 82 YR
• Patient Sex: Male