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
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 she has had multiple utis with use of this product.She states she has had multiple utis in the past with use of this product.Consumer is a 75-yr old t3 sci paralyzed female in wheelchair.Suffers from arthritis as well.She states she caths 3 - 5 times a day.She has used this product for about 9 - 10 yrs she estimates.She said, however, she started cic about 15 yrs ago and ever since she started self catheterization she has had utis.Her understanding from her doctor is because she catheterizes she is more prone to utis.She cannot quantity exactly how many she has had over the years but she said it has been many.She said she always takes precautions to wash her hands, uses adult cleansing wipes in her genital area to cleanse urethra and ensures to not contaminate the catheter but she is prone to them.She said in the remote past her worst uti she was hospitalized for a few days due to an e.Coli infection found in her urine that made her septic.She said currently she has a uti that was found via urine culture.She said her symptoms are typically usually lower back pains, tired feeling.She has completed 10 days of an antibiotic pill (name cno) she has had to take twice a day but it has caused her diarrhea, and she said her symptoms are not better.She has to go tomorrow to recheck her urine and her urologist has requested her to come in for an appointment to discuss as well before prescribing any more antibiotics.She is also often constipated.No photo available.

• 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 ; 3365424679
• MDR Report Key: 23406145
• Report Number: 1049092-2025-00250
• Device Sequence Number: 4940234
• Product Code: KOD
• UDI-Device Identifier: 00815947020383
• UDI-Public: 00815947020383
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/23/2025

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: T12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 10/28/2025
• 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: 75 YR
• Patient Sex: Female