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

Model Number	T10
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 cloudy urine after use.Per additional information received, end user received antibiotics for another uti she was diagnosed with due to the cloudy urine observed.A separate emdr has been submitted for the previous uti.
Additional Manufacturer Narrative
Investigation findings: ¿ retained samples: packaging intact, passed dye penetration seal tests.¿ sterilization: eo sterilization confirmed effective; biological indicators met standards.¿ lubricant gel: microbial limits within spec; no pathogens detected; gel confirmed sterile.¿ assembly & sealing: all bonding and heat-sealing processes followed sops; no sealing defects found.¿ staff: properly trained and certified; no health or performance issues.¿ machines: sterilizers and incubators maintained and validated; no faults reported.Root cause & corrective action: ¿ root cause: no product-related cause identified.Sterility and sealing integrity confirmed.¿ likely factors: uti may stem from procedural issues or individual health factors (e.G., contamination during menstruation, personal hygiene, immune response).¿ corrective action: none taken; no product defects found.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
To date no additional patient or event details have been received.

• 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: 22342511
• Report Number: 1049092-2025-00190
• Device Sequence Number: 11987240
• Product Code: KOD
• UDI-Device Identifier: 00815947020376
• UDI-Public: 00815947020376
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 06/13/2025

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: T10
• Device Lot Number: 24B24805
• 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: 06/13/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2024
• 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: 39 YR
• Patient Sex: Female