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

Model Number	T12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation considered user-specific factors (e.G., sensitive skin, improper handling, physiological differences) as potential causes of the reported issues.Sterilization efficacy of both batches was validated, ruling out contamination from the product itself.Manufacturing and sterilization processes adhered to strict protocols (e.G., routine maintenance, biological indicator verification).Conclusion: the product sterility and quality were confirmed as compliant, eliminating the possibility of product-related uti causes.Discomfort and infection were attributed to user-specific factors or external handling procedures rather than product defects.Actions taken: no corrective measures were recommended, as the investigation did not find faults with the product or manufacturing processes.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.
Additional Manufacturer Narrative
The investigation considered user-specific factors (e.G., sensitive skin, improper handling, physiological differences) as potential causes of the reported issues.Sterilization efficacy of both batches was validated, ruling out contamination from the product itself.Manufacturing and sterilization processes adhered to strict protocols (e.G., routine maintenance, biological indicator verification).Conclusion : the product sterility and quality were confirmed as compliant, eliminating the possibility of product-related uti causes.Discomfort and infection were attributed to user-specific factors or external handling procedures rather than product defects.Actions taken : no corrective measures were recommended, as the investigation did not find faults with the product or manufacturing processes.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.
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 states after use of the product for 1 week "she developed a uti and thinks it was from the t12 catheter." she had pain with insertion and removal.She said she "typically washes her hands 2 x, cleanses her meatus with as sensitive skin wipe prior to cathing and uses a large mirror to get the catheter in urethra, she said the catheter always goes in directly into urethra and she is careful to not contaminate it in any way prior.She then drain urine but it is painful while the catheter goes in to her urethra and then when she removes it but pain goes away when she removes it.Last week though she said her urine started to smell very bad and then she started to have burning that kept getting worse.She said it even hurt at night.She went to cvs to get some cream and pills to try and help her urethral pain (names unknown) and she said by sunday it started burning so bad as well as itching and she even noted white discharge with cathing so she went into the er and they did urine testing and she was diagnosed with a uti.She stopped cathing and took antibiotics (name unknown) prescribed from er which she said "really helped" her symptoms.She is unsure if possibly sensitive to lubricant as she said she has always had sensitive skin in general." end user states she has hard stools and has a history constipation.End user is following up with her medical doctor.

• Brand Name: CURE PRODUCTS
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; 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 ; 3367062840
• MDR Report Key: 21113301
• Report Number: 1049092-2025-00011
• Device Sequence Number: 21015988
• Product Code: KOD
• UDI-Device Identifier: 00815947020383
• UDI-Public: 00815947020383
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/06/2025

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
• Device Lot Number: 23B21201
• 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: 01/06/2025
• Supplement Date Received by Manufacturer: 04/17/2025; 04/17/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 04/24/2025; 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female