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

Model Number	HM14C
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 reported he had 2 recent utis.He had his first uti in early september which he said he had frequency, urgency, bleeding noted in his urine and his prostate was swollen.He saw his md and had urine testing.The bacteria aerococcus was found in his urine and he was prescribed nitrofurantoin which resolved his symptoms.His md said this bacteria is rare but often found in hospitals but his only prior intervention was in june with the urolift but it was possibility from that.Then 2.5 - 3 weeks later he had urgency frequency again and that time was getting his urine checked for a physical and the bacteria that grew out was enterococcus.It was deemed his second uti; he was prescribed amoxicillin and finished that course last sat and is feeling better.His md mentioned that sometimes enterococcus can grow when an aerococcus infection was recently treated.There was no additional information provided.
Additional Manufacturer Narrative
Investigation findings 1.Raised bumps on hnc catheter: analysis & inspection: 13 retained samples were tested; no similar defects found.Possible causes: speculated to be extrusion defects or bending during transportation.Manufacturing process review: equipment was functioning correctly, material was within specifications, and quality checks were conducted regularly.Conclusion: no definitive root cause determined due to lack of physical samples or images from the user.2.Burning sensation from ultra catheter: possible causes: inadequate gel application, leading to insufficient lubrication.Pre-existing urethral mucosal damage, which could be exacerbated.Production review: gel filling machine was within specification, and no anomalies were detected.Conclusion: since batch details were unavailable, the investigation could not determine the root cause.This investigation will be closed.This issue will be monitored through the post market product monitoring review process, sop-000741.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 ; 3367062840
• MDR Report Key: 20571282
• Report Number: 1049092-2024-00130
• Device Sequence Number: 8575392
• Product Code: EZD
• UDI-Device Identifier: 00815947020345
• UDI-Public: 00815947020345
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2024

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: HM14C
• Device Lot Number: 23B18201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 05/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2023
• 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