MAUDE Adverse Event Report: CONVATEC CURE CATHETER; CATHETER, URETHRAL

Model Number	M16C
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
(b)(6) year old end user reports he has had "infections in the bladder" in his past and his doctor has needed to give him medicine for at time but doesn't know if possibly this could be caused by using catheters.No additional information was provided.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Investigation: this complaint has been evaluated.Integral conducted a comprehensive investigation including: - retained sample testing.- 5m1e review (man, machine, material, method, environment, measurement).- production record and dhr review.- packaging equipment assessment.- on-site manufacturing observations.- user operation risk assessment.Key findings: product / manufacturing investigation: - 13 retained samples from the reported lot were tested, and none showed adhesion to the packaging.All catheters could be removed normally.- no residue or contamination was found on the catheter surfaces or inside the packaging.- packaging equipment, process parameters, moulds, sterilization processes, environmental controls, and inspection records were all found to be within specification and compliant with requirements.- raw materials (pvc, blister film, blister paper) met specifications, and no material changes or mixing risks were identified.- additional observation of current production batches found no catheter-to-packaging adhesion issues.Root cause for packaging adhesion: - the investigation did not identify a manufacturing defect or systemic quality issue.- no evidence was found that the catheter material could chemically bond to the blister packaging under normal conditions.- because the complaint sample was not returned, the actual defective product could not be analyzed.- therefore, the root cause of the reported adhesion could not be confirmed.Uti risk assessment: - the investigation highlighted a potential user-related risk: - the customer reportedly applied lubricant to non-sterile gloves and then transferred it to the catheter before use.- integral concluded that this practice could transfer microorganisms onto the catheter and provide a pathway for pathogens into the bladder.- the report identifies this as the most likely cause of the customer's reported uti, rather than a product defect.Corrective and preventive actions (capa): customer-use recommendation: - stop applying lubricant via non-sterile gloves.- use sterile lubricant directly on the catheter or use sterile gloves during catheterization.Supplier investigation report attached to child record.This investigation will be closed.This issue will be monitored through the post market product monitoring review process, (b)(4).

• Brand Name: CURE CATHETER
• Common Device Name: CATHETER, URETHRAL
• 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: pam meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; +1(603)247-0255
• MDR Report Key: 25378462
• Report Number: 1049092-2026-00144
• Device Sequence Number: 13403929
• Product Code: GBM
• UDI-Device Identifier: 00815947020093
• UDI-Public: 00815947020093
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2026

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: M16C
• Device Lot Number: 25B17704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2026
• Supplement Date Received by Manufacturer: 07/22/2026
• Initial Report FDA Received Date: 06/03/2026
• Supplement Report FDA Received Date: 07/27/2026
• Date Device Manufactured: 07/01/2025
• 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 Sex: Male