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

Model Number	ULTRA10
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 states "she is not blaming any defect on this product but rather just the act of cathing she was told by her md places her susceptible to utis." she reports having "more utis with use of this catheter than any other she has previously used, although she has had prior utis before.She states she no longer has pain/ pinching feeling with this catheter - caths 6-7 x day.She thinks her interstitial cystisis was the cause of that feeling she previously had this with product but she has never gotten so many utis in a short time frame, more so than ever previously with any other catheter and she called to report this and explore other options.She said she has always closely followed up with her urologist; also with infectious disease.She has had a recent urodynamics, cystoscopy and renal us.She has a small kidney stone in her left kidney but they are just monitoring it now.She said her uti symptoms are usually urgency, frequency, bladder pain burning and chills and then she goes into do a urine sample.This year with use of this catheter she has been diagnosed with a uti in february - e.Coli.Symptoms cleared after oral antbiotic treatment - name unknown.(b)(6) - diagnosed with klebsiella p.- treated with iv rocephin for 5 days and then after that, between (b)(6) her symptoms never cleared despite that iv treatment so she did another urine sample and she was diagnosed with e.Coli.She was prescribed bactrim them changed to macrobid to treat this.She just had a urine specimen now that was clear of any infection feeling better now." ens user states "her cathing technique - she is doing all correctly to prevent utis.She cleanses hands appropriately, cleanses her urethra and does not contaminate the catheter prior to use.".This emdr covers the unknown number of catheters associated with the utis.
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 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: 19358494
• Report Number: 1049092-2024-00067
• Device Sequence Number: 17093343
• Product Code: KOD
• UDI-Device Identifier: 00815947020420
• UDI-Public: 00815947020420
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 05/20/2024

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 Expiration Date: 09/28/2025
• Device Model Number: ULTRA10
• Device Lot Number: 22B26301
• 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: 05/20/2024
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2022
• 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: 66 YR
• Patient Sex: Female