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

Model Number	T14
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 reports "some caps, she cannot even get open, they will not turn at all and has even asked help from her sister who also cannot even get some open and they have to discard without using them.Some open easily (as she is used to with this product, despite not having the best hand dexterity) and others are impossible to open having to struggle with them to get them to open.She said she isn't sure if this caused it but she was diagnosed with uti this past week using these.She said she hasn't had a uti in a couple years and last week started to have frequency, her back started to hurt and she felt "miserable." she did a urine sample as ordered by her md and a uti was confirmed.She was started on an antibiotic and then switched to a different one (name/s unknown when the urine culture came back and is only on day 2 of taking that new treatment course.She states she always washes her hands, uses 2- 3 wipes to cleanse her urethra with prior to insertion each time and ensures the catheter stays sterile prior to use.".
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be a serious injury.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 TWIST
• 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: 23050433
• Report Number: 1049092-2025-00226
• Device Sequence Number: 13139564
• Product Code: KOD
• UDI-Device Identifier: 00815947020390
• UDI-Public: 00815947020390
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 09/11/2025

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: T14
• Device Lot Number: 25B02804
• 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: 09/11/2025
• Initial Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2025
• 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: 80 YR
• Patient Sex: Female