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

Model Number	T12
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
Additional Manufacturer Narrative
E.1: (b)(6) 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.Fda registration number reporting site: 1049092 manufacturing site: 3005471919.
Event or Problem Description
End user reports notes she was on a 23 day cruise in december and said she had uti symptoms and had to get off the ship in the (b)(6) to buy antibiotics (as there she could purchase them without a prescription).Her symptoms never cleared with those, and she had to follow up with her md at home and had to be placed on 1 very strong antibiotic she had to take "3 different doses" of.She said she is resistant to many antibiotics as she has delt with recurrent utis in the past and even had to be on prophylactic antibiotics daily in the past.She said she followed up with her md recently and she has fully cleared the infection.No additional information was provided.This emdr covers the unknown number of catheters with unknown lot numbers of the same catheter associated with the uti.
Additional Manufacturer Narrative
Investigation: this complaint has been evaluated as a type 6 case.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, sop-000741.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: CURE TWIST
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): CONVATEC; 7815 national service road; suite 600; greensboro NC 27409
• Manufacturer (Section G): CONVATEC; 7815 national service road; suite 600; greensboro NC 27409
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 6032470255
• MDR Report Key: 24547730
• Report Number: 1049092-2026-00054
• Device Sequence Number: 5725376
• Product Code: KOD
• UDI-Device Identifier: 00815947020383
• UDI-Public: 00815947020383
• Combination Product (Y/N): N
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

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: T12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/08/2026
• 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: Female