MAUDE Adverse Event Report: CONVATEC CURE PRODUCTS; CATHETER, STRAIGHT

Model Number	HM14
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
E.1: complainant street address: (b)(6) patient country: united states.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 recent uti with use of product.He further states he was recently in the hospital for heart concerns, placed on multiple antibiotics to go home with he said but just today got called in an alternative antibiotic for a uti that grew out in his urine culture and was finalized today.He said his urine is dark and that is his only symptom despite him pushing fluids.He said he has had multiple utis in the past but that is usually whenever he runs out of this catheter and has to purchase out of pocket uncoated catheters he has to apply lubricant to.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Investigation: this product was shipped from ups louisville to the customer.Ups quality & operations have investigated and confirmed the following; - lot 24b10302 was packed & loaded correctly at ups - ups received no returns on this lot - they also shared the recall report for this lot & none were requested by cardinal health therefore the likely root cause of this issue is damages that have occurred during transit outside of convatec control.No additional details have been provided to date.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, STRAIGHT
• 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: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 21360696
• Report Number: 1049092-2025-00054
• Device Sequence Number: 20962163
• Product Code: EZD
• UDI-Device Identifier: 00815947020314
• UDI-Public: 00815947020314
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2025

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: HM14
• Device Lot Number: 24B10302
• 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: 01/21/2025
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2024
• 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 Sex: Male