MAUDE Adverse Event Report: CONVATEC INC CURE PRODUCTS; 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
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.
Event or Problem Description
End user reports experiencing "multiple "back to back" diagnosed utis while using this product." end user states "she used to cath regularly in 2022 for urinary retention.Prior to this she said she had a foley placed.She does not know the cause of her retention but was directed to stop cathing after having recurrent utis when she would cath regularly.The time she cathed regularly was in 2022 for a few months she thinks from (b)(6) 2022.She called today to ask if anything about the t14 catheter could contribute to her past utis, unsure of her cause of so many utis when she would cath.Very difficult for her to remember details and does not know exact qty of diagnosed utis only states they were "back to back each month she cathed" as it was so long ago.She said as soon as she would stop taking the various antibiotic treatment courses (she said she tried a variety of them as prescribed only remembers the name cipro - denies being on any prophylaxis course) the symptoms of frequency, urgency would come back and once she said experienced fever and chills.She takes cranberry pills for prevention.She does not know if the bacteria found in her urine each time she had a urine test (ua and culture) done was different or the same.She said the md even did a "procedure" in office for uti prevention but it did not help.She said she also has ibs, diverticulitis, colitis and often periods of constipation.Explained to her the connection between constipation and utis.She isn't sure if she fully drained her bladder when she cath'd regularly and these utis occurred.She did used to keep a urine voiding diary of her voids when she cath'd for her md.She said she always washed her hands prior to cathing but did not cleanse her urethral opening prior to placing the catheter." it was explained to her how important that can be to uti prevention, she was appreciative of that info.She said "this past monday she went in for a cat scan and mri and it showed very large urinary retention and she did cath for the first time on her own accord yesterday and got out urine but didn't feel like she fully drained.Today she has an appointment with her urologist as she has to discuss 2 options that have been presented to her, to start cathing again or have a surgical procedure.".
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Per the investigation, the sterilization of lot 22b10601 is qualified.The products are sterile, and the product itself will not cause utis.The merck manual of diagnosis and treatment of urinary tract infection (uti overview) mentions: bacteria usually come from the intestines or vagina, and more than 85% of uti are caused by bacteria in these parts.Regarding to ¿whether t14 catheter could contribute to her past utis¿, the investigation results show the products are sterile and the product itself will not cause uti.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092, manufacturing site: 3005471919.

• 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: 20407762
• Report Number: 1049092-2024-00121
• Device Sequence Number: 3351479
• Product Code: KOD
• UDI-Device Identifier: 00815947020390
• UDI-Public: 00815947020390
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 10/03/2024

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: 22B10601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: 11/28/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2022
• 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: 78 YR
• Patient Sex: Female