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

Model Number	421910
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 reported notch on funnel and coude tip not aligned.He stated every one he used was off by varying angles and just not aligned.He did mention as an example if one is misaligned by 35 degrees and he has to angle the catheter differently so he can use them comfortably so as to avoid bleeding.There was no harm reported.No additional information was provided.

• Brand Name: GENTLECATH
• Common Device Name: CATHETER, URETHRAL
• 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: 24747581
• Report Number: 3005778470-2026-00538
• Device Sequence Number: 9230021
• Product Code: GBM
• UDI-Device Identifier: 30768455153825
• UDI-Public: 30768455153825
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: 421910
• Device Lot Number: 5F01409
• 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: 03/26/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/14/2026
• Date Device Manufactured: 06/06/2025
• 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: Male