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
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 uti diagnosed shortly after use.Consumer is not new to this product, has been using it for a long time and it has always worked well for him.He caths typically 2-3 times a day recently switched to 4 times day for retention.He has history of a bladder diverticulum and one non-functioning kidney.He had surgery to remove both in the past.He said his urine began to be malodorous and he didn't feel good and had a low-grade fever so he went to urgent care and they did urine testing and his urine culture grew out klebsiella.He said he has had this bacteria before in the past but he has not had a uti in long while.He was prescribed keflex as well as a probiotic to help with constipation and this has helped him, feeling better now.
Additional Manufacturer Narrative
Investigation findings: sticky texture confirmed in returned samples.No abnormalities found in manufacturing or inspection records for the lot.Traceability review revealed raw material batch (200709132) was previously linked to another complaint (capa21052502).Root cause & corrective action: the issue traced to the previously implicated raw material from hopefinder (mt-8013ta).Manufacturer discontinued use of mt-8013ta material as of may 21, 2021.No further corrective actions deemed necessary.Supplier report has been attached to child investigation record.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, 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: 21968163
• Report Number: 1049092-2025-00150
• Device Sequence Number: 20863843
• Product Code: EZD
• UDI-Device Identifier: 00815947020314
• UDI-Public: 00815947020314
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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 Expiration Date: 09/01/2025
• Device Model Number: HM14
• Device Lot Number: 201028-1
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 07/29/2025
• Date Device Manufactured: 10/01/2020
• 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 Sex: Male