MAUDE Adverse Event Report: UNOMEDICAL S.R.O. GENTLECATH; CATHETER, UROLOGICAL

Model Number	421909
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
End user reports many of the guide notch on funnel not perfectly aligned with the coude tip.He states in the past half a year he has used this particular catheter, he has noticed maybe one or 2 not aligned in a box and never said anything.He spoke up because in this order nearly every single catheter from the first box he used up was like this and now he is on boxes 2 and 3 and said the majority are like this as well.He reports the tip and the notch on the funnel are not perfectly aligned.He said it is off by about 15 degrees.He said as an example if the guide is at 12 o clock the coude tip is pointing at 11:45 on a clock.No photo available.There was no harm.This emdr covers the unknown number of catheters associated with this lot#.

• 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: courtney smith ; 7815 national service road; suite 600; greensboro, NC 27409 ; 6032470255
• MDR Report Key: 24912651
• Report Number: 3005778470-2026-00580
• Device Sequence Number: 9085804
• Product Code: KOD
• UDI-Device Identifier: 30768455153818
• UDI-Public: 30768455153818
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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: 421909
• Device Lot Number: 5K04306
• 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: 04/10/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 05/23/2026
• Date Device Manufactured: 10/17/2025
• 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 Age: 76 YR
• Patient Sex: Male