MAUDE Adverse Event Report: Unomedical s.r.o. GENTLECATH; Catheter, Urological

Model Number	421911
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
End user reports possible structural irregularity with rough tip.Reports ¿some of the products did feel rough at the tip when trying to insert.The curve of the tip seemed to be different or even the size of the tube, it is not a difference you can see.¿ no photo available.There was no harm reported.No further information obtained.
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be a reportable malfunction.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: 3005778470.

• Brand Name: GENTLECATH
• Common Device Name: Catheter, Urological
• Manufacturer (Section D): Unomedical s.r.o.; priemyselny park 3,; michalovce 07101 ; LO 07101
• Manufacturer (Section G): Unomedical s.r.o.; priemyselny park 3,; michalovce 07101 ; LO 07101
• Manufacturer Contact: armando cuello ; 7815 national service road; suite 600; greensboro, NC 27409 ; +1(603)247-0255
• MDR Report Key: 50867484
• Report Number: 3005778470-2026-000086
• Device Sequence Number: 15808919
• Product Code: KOD
• UDI-Device Identifier: 30768455153832
• UDI-Public: 30768455153832
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 421911
• Device Lot Number: 5L02849
• 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: 09/10/2026
• Initial Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 11/14/2025
• 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: Unknown